Severity Of Menopausal Symptoms Research Articles

Associations of menopausal symptoms with job-related stress and social support in Japanese school teachers

ObjectivesBeing a school teacher is highly stressful. This study aimed to clarify the prevalence of menopausal symptoms and explore the association between these symptoms and job-related stress among Japanese school teachers. Study designA cross-sectional study was conducted among randomly selected elementary and junior high school teachers in Japan. Data from 284 teachers aged 45–60 years were analyzed. Main outcome measuresMenopausal symptoms were measured using the Greene Climacteric Scale, and the Brief Job Stress Questionnaire was used to assess job stressors, social support, and job/family satisfaction. Associations between scores on the Greene Climacteric Scale and on the Brief Job Stress Questionnaire, and demographic information were analyzed. ResultsThe most common menopausal symptom was “feeling tired or lacking in energy” (reported by 94.4 % of menopausal respondents). The total intensity of menopausal, psychological, and somatic symptoms was significantly correlated with the total level of job stress. Moderate correlations were found between depressive symptoms and job stress regarding suitable jobs, job control, and rewarding jobs, while weak correlations were evident between depressive symptoms and job stress regarding quantitative job overload, interpersonal conflict, and poor physical environment. Higher levels of perceived support from supervisors or co-workers and job satisfaction were associated with less severe psychological and somatic symptoms. ConclusionsMost middle-aged school teachers felt tired or lacking in energy. Higher job-related stress and lower levels of support from supervisors or co-workers were correlated with more severe menopausal symptoms. A supportive work environment and stress management are essential for such teachers.

Patient-reported sexual health outcomes of cervical cancer patients treated with definitive chemoradiation and MRI-guided brachytherapy

BackgroundSexual health is an important survivorship issue in cervical cancer. We assessed patient-reported sexual health outcomes and correlations with oncologist-assessed vaginal toxicity (VT). MethodsThis was a prospective, cross-sectional study of stage IB-IVA cervical cancer patients treated with definitive chemoradiation, who completed a socio-demographic questionnaire and the following patient-reported-outcomes (PROs): Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS-R), Menopause Rating Scale (MRS), Hospital Anxiety and Depression Scale (HADS). VT was assessed using the CTCAE v4.0. Sociodemographic, clinical data, PROs and VT were summarized using descriptive statistics; correlations were evaluated using linear regression analyses. ResultsBetween August 2018 and April 2022, 73 patients were analyzed. Median age was 49 (range 25–81), 57.5% had vaginal involvement at diagnosis and 76.9% were partnered. Sexual dysfunction (FSFI score ≤ 26), sexual distress (FSDS-R ≥ 11), severe menopausal symptoms (MRS ≥ 17), anxiety (HAD-Anxiety >7) and depression (HAS-Depression >7) were reported in 86.3%, 54.5%, 36.2%, 46.6% and 24.7%, respectively. Grade 2+ VT was reported in 27.4%. No significant associations were found between PROs and VT. On multivariable analysis, non-partnered status, use of hormone replacement therapy, and International Commission on Radiation Units and Measurements – rectovaginal dose (ICRU-RV) >65Gy were associated with worse sexual health (p < 0.005). ConclusionCervical cancer patients self-report high rates of sexual distress, dysfunction and menopause symptoms. Discordance between oncologist-assessed VT and PROs highlights the importance of evaluating the patient's experience. Proactive treatment of menopausal symptoms and attention to radiotherapy doses to the vagina should be considered.

Cinnamon potential in alleviating early postmenopause symptoms: a randomized clinical trial

Abstract Objective Menopause is a substantial physical, mental, and emotional transition in a woman's life. Most women suffer symptoms during menopause, impacting their quality of life for a decade or more. This study aimed to determine the effect of cinnamon on the severity of postmenopause symptoms. Methods A randomized, triple-blind, parallel clinical trial was conducted on 60 postmenopausal women in the health centers of Hamadan, Iran. The study included women aged 45 to 60 years who were 1 to 3 years after their last menstrual period. The participants were assigned to two groups using a permuted block randomization method. The intervention group received a daily dose of one cinnamon capsule (1 g) for 2 months, whereas the control group received a placebo. The participants, researchers, and statistical analysts were all blinded. The study measured the severity of menopause symptoms using the Menopause Rating Scale before and 2 months later. Data were analyzed using Stata-13 software. Results Data from 59 individuals were analyzed. The analyses were adjusted for baseline Menopause Rating Scale scores. After the intervention, the severity of menopause symptoms was lower in the intervention group (13.95 ± 4.16) compared to the control group (16.64 ± 4.16) (P = 0.01), with an effect size of 0.65 (95% CI, 0.12-1.17). Additionally, the intervention group had lower scores for psychological symptoms compared to the control group (P = 0.006), with an effect size of 0.74 (95% CI, 0.21-1.27). Conclusions The consumption of cinnamon in postmenopausal women has been found to improve the severity of menopause symptoms, with a particular emphasis on the psychological domain.

Association of insurance type with unmet need for menopause care in Oregon.

To determine unmet need for menopause care in Oregon and evaluate if insurance type is associated with receipt of care. We conducted a cross-sectional survey of patients using an Oregon Listserv. Our primary outcome was use of medication for the treatment of moderate or severe symptoms of menopause. We used the Menopause Rating Scale to evaluate respondents' symptoms: 0-4 none or little symptoms; 5-8 mild symptoms; 9-16 moderate symptoms; and 17+ severe symptoms. We abstracted demographic and clinical information including age, rurality, race, ethnicity, primary language, and insurance type. We used a regression model to determine the association between public insurance and treatment for moderate to severe menopause symptoms. We examined reasons for nonuse of therapy. Our sample included 845 perimenopausal or postmenopausal individuals who were predominantly White (93.0%), aged 45-49 (32.8%) or 50-54 years (39.1%), and privately insured (81.3%). Overall, 62.4% of individuals with moderate and severe symptoms of menopause were not receiving any therapy. After adjustment for age and rurality, public insurance was associated with an average of 47% increased odds of nontreatment for moderate or severe menopause symptoms (adjusted odds ratio: 1.47, 95% CI: 0.99-2.19). The most common reasons for nontreatment in both groups were "therapy was not recommended by a provider" (43%) and worries about safety or side effects (40%). Even in well-insured persons, the majority of people with moderate and severe symptoms of menopause are not receiving treatment. People who are publicly insured are more likely to go untreated than privately insured individuals.

The role of cardiorespiratory fitness and body composition in the association between physical activity and menopausal symptoms.

The aim of the study was to conduct exploratory analyses on the role of cardiorespiratory fitness (CRF) and body composition in the association between physical activity and menopausal symptoms. This was a cross-sectional (N = 298) study of women aged 51-59 years including a subsample of 82 women followed for 4 years. The severity of menopausal symptoms was assessed with the Menopause Rating Scale in total symptoms as well as using the somato-vegetative, psychological, and urogenital subscales. Physical activity was assessed with accelerometers and self-reports, body composition with dual-energy x-ray absorptiometry, and CRF with a custom-made prediction model based on the six-minute walking distance and spiroergometry. The associations of interest were studied using unstandardized regression coefficients derived from multiple linear regression models with the severity of menopausal symptoms as the outcome. Higher total body and fat mass (kg) were associated with more severe total symptoms (B = 0.06 [95% CI, 0.01 to 0.12] and 0.07 [0.01 to 0.14], respectively) as well as somato-vegetative (0.03 [0.01 to 0.05]; 0.04 [0.01 to 0.06]) and psychological symptoms (0.03 [0.00 to 0.05]; 0.03 [0.00 to 0.06]) in cross-sectional design. Total and lean body mass interacted with physical activity in total and psychological symptoms with stronger indirect associations being observed in participants with lower total and lean body mass. CRF was not associated with menopausal symptoms and did not interact with physical activity. Maintaining a healthy weight is associated with less severe menopausal symptoms in middle-aged women. The association between physical activity and the severity of menopausal symptoms varied based on the differences in total and lean body mass.

Association Between Menopausal Symptoms and Work-Related Factors Among Female Workers in Japan: A Cross-Sectional Study.

Although menopausal symptoms are an important issue for female workers, their association with work-related factors is not well studied. Here, we explored the association between work-related factors and menopausal symptoms in Japan. A cross-sectional study was conducted in 2023 among all 1465 female employees of a large Japanese company. Associations between occupational factors and moderate or severe menopausal symptoms, as measured by the Menopause Rating Scale (MRS), were examined using logistic regression analysis. Several workplace-related factors were significantly associated with moderate or severe menopausal symptoms, including company support and the number of night shifts. A marginally significant association was also seen for commuting time. Workplace menopause interventions for the factors identified in this study may satisfy unmet needs.

Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause

Safe and effective nonhormonal treatments for menopausal vasomotor symptoms (VMS) are needed. To evaluate the efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist, for the treatment of moderate to severe menopausal vasomotor symptoms. Two randomized double-blind phase 3 trials (OASIS 1 and 2) included postmenopausal participants aged 40 to 65 years experiencing moderate to severe vasomotor symptoms (OASIS 1: 77 sites in the US, Europe, and Israel from August 27, 2021, to November 27, 2023, and OASIS 2: 77 sites in the US, Canada, and Europe from October 29, 2021, to October 10, 2023). Once daily oral elinzanetant, 120 mg, for 26 weeks or matching placebo for 12 weeks followed by elinzanetant, 120 mg, for 14 weeks. Primary end points included mean change in frequency and severity of moderate to severe vasomotor symptoms from baseline to weeks 4 and 12, measured by the electronic hot flash daily diary. Secondary end points included Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b total T score and Menopause-Specific Quality of Life questionnaire total score from baseline to week 12. Eligible participants (mean [SD] age, OASIS 1: 54.6 [4.9] years; OASIS 2: 54.6 [4.8] years) were randomized to elinzanetant (OASIS 1: n = 199; OASIS 2: n = 200) or placebo (OASIS 1: n = 197; OASIS 2: n = 200). A total of 309 (78.0%) and 324 (81.0%) completed OASIS 1 and 2, respectively. For the elinzanetant and placebo groups, the baseline mean (SD) VMS per 24 hours were 13.4 (6.6) vs 14.3 (13.9) (OASIS 1) and 14.7 (11.1) v 16.2 (11.2) (OASIS 2). Baseline VMS severity was 2.6 (0.2) vs 2.5 (0.2) (OASIS 1) and 2.5 (0.2) vs 2.5 (0.2) (OASIS 2). Elinzanetant significantly reduced VMS frequency at week 4 (OASIS 1: -3.3 [95% CI, -4.5 to -2.1], P < .001; OASIS 2: -3.0 [95% CI, -4.4 to -1.7], P < .001) and at week 12 (OASIS 1: -3.2 [95% CI, -4.8 to -1.6], P < .001; OASIS 2: -3.2 [95% CI, -4.6 to -1.9], P < .001). Elinzanetant also improved VMS severity at week 4 (OASIS 1: -0.3 [95% CI, -0.4 to -0.2], P < .001; OASIS 2: -0.2 [95 CI, -0.3 to -0.1], P < .001) and week 12 (OASIS 1: -0.4 [95% CI, -0.5 to -0.3], P < .001; OASIS 2: -0.3 [95% CI, -0.4 to -0.1], P < .001). Elinzanetant improved sleep disturbances and menopause-related quality of life at week 12, and the safety profile was favorable. Elinzanetant was well tolerated and efficacious for moderate to severe menopausal VMS. ClinicalTrials.gov Identifier: OASIS 1: NCT05042362, OASIS 2: NCT05099159.

Severe menopausal symptoms linked to cognitive impairment: an exploratory study.

To evaluate the association between menopausal symptoms and cognitive decline in postmenopausal women. This was a subanalysis of a cross-sectional, observational study conducted among women attending gynecological consultations across nine Latin American countries. The survey involved late postmenopausal women who were asked to complete a general questionnaire and the Menopause Rating Scale (MRS) to assess menopausal symptoms, with the Montreal Cognitive Assessment used to evaluate cognitive function as an outcome. A Montreal Cognitive Assessment score of less than 21 was used to define women with mild cognitive impairment (MCI). The study included 1,287 postmenopausal women with a mean age of 55.5 years and a mean body mass index of 26.3 kg/m2. On average, participants had 13.8 years of education and 2.3 ± 1.8 children, with 72.8% reporting having a partner. Additionally, 36.7% ever used menopausal hormone therapy. Regarding lifestyle factors, 50.3% engaged in a sedentary lifestyle, whereas 70.5% had never smoked. 15.3% of women had MCI exhibited significantly more intense menopausal symptoms compared with those without MCI (MRS total score 15.24 ± 12.58 vs 10.53 ± 8.84, respectively, P < 0.001). Logistic regression analysis revealed a significant association between severe menopausal symptoms (MRS total score ≥14 points) and MCI (odds ratio [OR], 1.74; 95% CI, 1.25-2.42). Conversely, a lower body mass index (OR, 0.96; 95% CI, 0.95-0.98), sexual activity (OR, 0.70; 95% CI, 0.51-0.96), physical exercise (OR, 0.55; 95% CI, 0.39-0.76), menopausal hormone therapy use (OR, 0.36; 95% CI, 0.24-0.55), and higher educational level (OR, 0.31; 95% CI, 0.21-0.46) were associated with lower odds for MCI. Severe menopausal symptoms in postmenopausal women were associated with cognitive impairment. This study highlights the intricate interplay between hormonal, lifestyle, and sociodemographic factors and cognitive health.

Increase Menopause Symptoms of Women with Hormonal Contraceptive in Surakarta

During menopause, a woman will experience physical and psychological changes which often cause various complaints. There are several factors that are thought to be the cause of these complaints, such as education, use of hormonal contraceptives, and psycholog. The purpose of this study was to determine the severity of menopausal symptoms in terms of history of contraceptive use. This type of research is descriptive quantitative with cross sectional data collection using the Menopause Rating Scale questionnaire, with sampling techniques using non probability consecutive sampling techniques. inclusion criteria women aged 45 - 59 years and have stopped menstruating, have a history of using hormonal contraceptives, willing to be a respondent conducted in March 2024 until the number of respondents was obtained 30 people. Univariate analysis test with frequency distribution. The results showed that the severity of menopausal symptoms in women using contraceptives was none 3%, mild 33%, moderate 37%, and severe 27%. Conclusion of this study is the severity of menopausal symptoms in women who use hormonal contraceptives on average have moderate severity. The severity of menopausal symptoms is not only influenced by contraceptive use, but there are other factors such as education and psychological conditions.

Adherence to a Mediterranean-style diet and severity of menopausal symptoms in perimenopausal and menopausal women from Australia: a cross-sectional analysis

PurposeTo explore the independent associations between adherence to a Mediterranean-style diet and severity of menopausal symptoms in perimenopausal and menopausal women living in Australia.MethodsDietary adherence was assessed using the Mediterranean Diet Adherence Screener (MEDAS), the Menopause Rating Scale (MRS) was used to assess the severity of menopausal symptoms, and the 36-item short form survey instrument (SF-36) was used to assess health-related quality of life (HRQoL).ResultsA total of n = 207 participants (50.7 ± 4.3 years; BMI: 28.0 ± 7.4 kg/m2) were included in the final analyses. Participants reported low-moderate adherence to a Mediterranean-style diet (5.2 ± 1.8; range: 1–11). Adherence was not associated with severity of menopausal symptoms. However, low consumption of sugar-sweetened beverages was inversely associated with joint and muscle complaints, independent of all covariates (β = -0.149; CI: -0.118, -0.022; P = 0.042). Adherence to a Mediterranean-style diet was positively associated with the physical function subscale of HRQoL (β = 0.173, CI: 0.001, 0.029; P = 0.031) and a low intake of red and processed meat was positively associated with the general health subscale (β = 0.296, CI: 0.005, 0.014; P = < 0.001).ConclusionDiet quality may be related to severity of menopausal symptoms and HRQoL in perimenopausal and menopausal women. However, exploration of these findings using longitudinal analyses and robust clinical trials are needed to better elucidate these findings.

Dietary Intake, Menopausal Symptoms, and Body Composition Associated with Possible Sarcopenia Among Vietnamese Middle-Aged Women: A Cross-Sectional Study.

Background: This study aims to investigate the prevalence of possible sarcopenia and its associated factors among middle-aged Vietnamese women. Methods: A cross-sectional study was conducted on 205 women aged 40-55 years who were admitted to the Can Tho Obstetrics and Gynecology Hospital between February and December 2023. The presence of possible sarcopenia was determined according to the AWGS 2019 criteria. Associated factors were dietary intake (total energy, protein, lipid, and carbohydrate intake), the severity of menopausal symptoms by using the Kupperman index, and body composition by using the bioelectrical impedance analysis device, Inbody S10. Logistic regressions were built to analyze the association between possible sarcopenia and its associated factors. Results: The prevalence of possible sarcopenia was 29.8%, with a mean age of 47.2. Possible sarcopenia was detected in 23% of the participants based on the criterion of low handgrip strength, whereas 83.6% of the participants when considered low performance in the chair stand test. Adjusted logistic regression analysis showed that living in a rural area (adjusted odds ratio [AOR]: 2.16, 95% confidence interval [95% CI]: 1.22-4.72), energy intake <25 kcal/body weight, (AOR: 1.94, 95% CI: 1.75-5.06), protein intake <0.91 g/body weight (AOR: 2.42, 95% CI: 1.51-5.76), skipping breakfast (AOR: 2.03, 95% CI: 0.91-4.54), mild menopausal symptoms (AOR: 2.68, 95% CI: 1.61-5.36), and obesity (AOR: 1.59, 95%CI: 1.29-3.67) were significantly associated with higher risk of possible sarcopenia. Conversely, higher muscle mass and higher upper limb mass were associated with a decreased risk of possible sarcopenia (total muscle mass AOR: 0.20, 95% CI: 0.07-0.59). Conclusions: These findings would provide a basis for enhancing management and prevention strategies to reduce the risk of sarcopenia in Vietnam. In particular, attention to nutrient intake and the management of menopausal symptoms may reduce the risk of sarcopenia.

Determining the Prevalence and Severity of Menopausal Symptoms in Post-Menopausal Women of Eluru, Andhra Pradesh, India, using the Menopause Rating Scale (MRS)

Background: This study aimed to assess the prevalence and severity of menopausal symptoms among women in Eluru, Andhra Pradesh, India, to better comprehend the specific challenges faced by rural women during this transitional phase. Methods: Post-menopausal women who visited the Rural Health and Training Center in Eluru between September-November 2021 and had one year of amenorrhea were included. A face-to-face interview administered a questionnaire to collect socio-demographic details and the Menopause Rating Scale (MRS) which contained 11 questions using a 4-point Likert scale. Microsoft Excel and SPSS-20, with one-way ANOVA test were used for data and statistical analysis. Results: A total of 100 respondents were included, aged between 45-60 years. Majority of the respondents (37%) were aged 45-50 years and were unskilled workers (53%) with a monthly income falling under the upper middle-class category (53%). Additionally, 61% belonged to nuclear families. Using the MRS, joint and muscle pains were the most prevalent symptoms (82%), followed by sleep problems (64%) and anxiety (57%). Heat discomfort was reported least frequently (25%). Age groups and symptom severity were found to be significantly associated, indicating that women between 45-50 years were more likely to experience mild-severe symptoms. Conclusion: This study identified a notable prevalence of menopausal symptoms among women in Eluru; however, limitations included the limited sample size and geographic scope. Retrospective data collection might have introduced recall bias. The study highlights the need for increased awareness and education on menopause. Community-based programs and health centers should be established to address these needs.

Associations between menopausal symptoms and cardiovascular disease in middle-aged Chinese women

Objective This study aimed to examine the association between severity of menopausal symptoms and cardiovascular disease (CVD) risk among middle-aged Chinese women. Methods A cross-sectional study recruited 9679 women aged 40–70 years from three socioeconomic regions of China in 2018. Menopausal symptoms were assessed by the modified Kupperman Menopausal Index (KMI). The severity of individual symptoms was classified as none (0 points), mild (1 points) and moderate-to-severe symptoms (2–3 points), and overall menopausal symptoms were classified as none (<15 points), mild (15–24 points) or moderate-to-severe (≥25 points) according to the sum score of the KMI. Logistic regression models were used to examine associations of the severity of menopausal symptoms with CVD risk. Results A total of 5.6% of participants reported being diagnosed with CVD. Overall menopausal symptoms were more common in women aged 60–70 years than in women aged 40–59 years. After multiple adjustment, mild (odds ratio [OR] = 2.07, 95% confidence interval [CI]: 1.64–2.61) and moderate-to-severe (OR = 2.64, 95% CI: 1.92–3.63) overall menopausal symptoms were associated with increased risk of CVD compared with no symptoms. Significant positive associations between the severity of individual menopausal symptoms and CVD risk were observed for all 13 items. Conclusion The severity of menopausal symptoms was positively associated with CVD risk in middle-aged Chinese women.

A review on association between menopausal symptoms and cardiovascular risk factors

Menopausal transition and post-menopausal periods can have short-term and long- term effects on mid-life health of women. The short-term effects include the possibility of experiencing of menopausal symptoms, while the long-term effects include cardiovascular diseases (CVD) risk. The occurrence of menopausal symptoms varies widely within and between populations. Studies indicate that the frequency and severity of menopausal symptoms are linked to CVD risk factors, but the existing literature is divergent and somewhat limited. Thus, women belonging to different populations are likely to be at a different risk of CVD, but the exact physiological mechanism behind this relationship remains unclear. The present narrative review aimed to synthesize the available evidence of menopausal symptoms in association with various conventional CVD risk factors such as blood pressure, total cholesterol and blood glucose levels and obesity, as well as to determine the potential link between these two processes. We undertook a rigorous data base search to identify, examine, and critically assess the existing literature on the associations between menopausal symptoms and CVD risk factors. We applied inclusion and exclusion criteria to filter the retrieved articles and classified the literature into eight major categories. The risk of CVD is higher among women who experience vasomotor, psychological, and urogenital symptoms compared to those who do not experience these symptoms. Our review indicates that menopausal symptoms can be used as markers in assessing CVD risk factors during midlife. Thus there is a need for larger-scale research to support these findings and identify the potential mediators that are controlling this association.

A phase III trial evaluating addition of adjuvant chemotherapy to ovarian function suppression + endocrine therapy in premenopausal women with pN0-1, HR+/HER2- breast cancer (BC) and oncotype recurrence score (RS) ≤25 (OFSET): NRG-BR009.

TPS612 Background: The TAILORx and RxPONDER trials demonstrated that RS identifies many postmenopausal pts with node-neg and node-pos BC and RS ≤25, who do not benefit from addition of ACT to endocrine therapy (ET). Both trials also showed that certain subsets of premenopausal pts (node-neg/high clinical risk/RS 16-20, node-neg/RS 21-25, and node-pos/RS ≤25) benefited from adding ACT to ET. Most premenopausal pts in these trials did not receive ovarian function suppression (OFS) as part of their ET regimen. Given the observed benefit from OFS in high-risk premenopausal pts with HR+/HER2- BC in the SOFT/TEXT trials, many questioned whether all or part of the observed ACT benefit in the TAILORx/RxPONDER trials may have been the result of chemotherapy-induced OFS. To address this question, we developed OFSET, a phase III, multicenter clinical trial comparing OFS+ET v ACT+OFS+ET. Methods: We hypothesize that addition of ACT to OFS+ET is superior to OFS+ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early-stage BC pts with HR+/HER2- tumors, and a 21-gene RS between 16-25 (for pN0 pts) and 0-25 (for pN1 pts). Secondary objectives include invasive disease-free survival, overall survival, distant recurrence-free interval, breast cancer-free interval, and health-related quality of life (HRQOL). Pts must be node-neg with RS 16-20 (plus high clinical risk), or RS 21-25, or have 1-3 positive nodes with RS ≤25. Stratification is by nodal status/RS status (pN0 RS 16-25 v pN1 RS 0-15 and pN1 RS 16-25), intent to receive CDK4/6 inhibitor (yes; no), and age (18-39 v ≥40). Pts are randomized after surgery to either OFS+ET or ACT+OFS+ET. ET is an aromatase inhibitor (AI). Choice is per investigator discretion; tamoxifen is allowed if AI is not tolerated or if OFS is incomplete. Radiotherapy will be administered per investigator discretion per protocol guidelines. The HRQOL substudy will assess differences in severe menopausal symptoms, measured by the FACT ESS-19 score between arms, as well as increased pain severity (PROMIS). Blood and tumor specimens will be collected for future research. Accrual of 3,960 pts is anticipated to be completed in 7 yrs, 7 mos. Per NSABP B-28 and RxPONDER data, 5yr IBCFS of pN1 pts on the ACT+OFS+ET arm is estimated at 92.3%. Based on TAILORx data, 5yr IBCFS of pN0 pts on the ACT arm is ~95%. Assuming 56% of pts to be pN0 and 44% pN1, and a 0.5% annual loss-to-follow-up rate, the definitive analyses to detect a hazard ratio: 0.75 with ACT+OFS+ET v OFS+ET, with one-sided α of 0.025 and 80% power, will require 380 IBCFS events, expected to occur~11 yrs after study initiation. OFSET was activated Aug 2023. Clinical trial information: NCT05879926 .

Switching from nonsteroidal aromatase inhibitors to exemestane and its impact on menopausal symptoms.

e13098 Background: Aromatase inhibitors (AIs) are the most used adjuvant treatment in post-menopausal women with favorable oncotype, hormone receptor-positive (HR+) early breast cancer. Nonsteroidal AIs, such as anastrozole and letrozole, are associated with menopausal side effects including arthralgias, vaginal dryness, and hot flashes. Steroidal AIs, such as exemestane, however, have mild androgenic activity, thus minimizing the risk for these side effects. While studies show exemestane exhibits less bone toxicity compared to anastrozole, there has not yet been a proven significant difference in all menopausal symptoms. Nevertheless, switching from nonsteroidal to steroidal AI is still commonly seen in clinical practice. In this study, we aimed to examine the impact of switching from nonsteroidal to steroidal AI on menopausal side effects. Methods: We performed a retrospective review of patients diagnosed with HR+ breast cancer managed at an urban academic center from 2010-2023. Patients initially treated with anastrozole or letrozole and switched to exemestane were identified. Pathology records, treatment plans, and documented side effects were abstracted from medical records, as were baseline demographics. Symptoms were graded based on severity before and after each hormone therapy: mild grade described intermittent symptoms that did not require intervention; moderate grade described persistent daily symptoms or those that improved with additional intervention; severe grade described persistent disabling symptoms that required change in hormone therapy. Wilcoxon signed-rank tests were used to compare severity of menopausal symptoms before and after switching to exemestane. Results: There were 128 patients included in the study. Median age at diagnosis was 62.5 years; 13% pre-menopausal, 80% post-menopausal, 4% perimenopausal, and 3% unknown. Most patients were diagnosed with invasive ductal carcinoma (80%) and 45% were found to have stage IA breast cancer. The median amount of time on first and second lines of endocrine therapy were 11 and 25 months, respectively. Ninety-six patients (75%) reported menopausal symptoms on nonsteroidal AI, and 66% subsequently switched to exemestane due to severity of these symptoms. The most reported symptoms were arthralgias (79%), hot flashes (27%), body aches (25%), fatigue (10%), and vaginal dryness (9%). Of those with menopausal symptoms, 51% noted a decrease in symptom severity after switching to exemestane: 4 improved from moderate to mild, 21 from severe to moderate, and 24 from severe to mild. This decrease in severity was statistically significant across all menopausal symptoms (p&lt;0.001). Conclusions: HR+ breast cancer patients exhibited a significant decrease in all menopausal symptoms when switching from nonsteroidal to steroidal AI. Further research is needed to examine the impact of this switch on a wider range of symptoms.

Cognitive shadows in perimenopause: linking subjective cognitive decline (SCD) to menopausal symptom severity.

As women approach perimenopause, the incidence of Subjective Cognitive Decline (SCD) rises. This study aims to investigate the association between SCD and the severity of perimenopausal symptoms. Conducted at The Affiliated Hospital of Guizhou Medical University Menopause Clinic from November 2022 to June 2023. Participants, aged 40-55 years, were classified as perimenopausal using the STRAW + 10 criteria. SCD was assessed separately using the Chinese version of the SCD-Q9 scale and the SCD International Working Group (SCD-I) conceptual framework, while perimenopausal symptoms were evaluated with the Modified Kupperman Index (MKI). Linear relationships between MKI scores and SCD-Q9 scores were clarified using both univariate and multivariate linear regression analyses. Additionally, a multivariate Logistic regression analysis was conducted to examine the association between MKI scores and SCD classification based on SCD-I criteria. The primary outcomes were the Modified Kupperman Index scores, SCD-Q9 questionnaire scores, and the diagnosis of SCD based on SCD-I criteria. Among 101 participants, the average MKI score was 18.90 ± 9.74, and the average SCD-Q9 score was 4.57 ± 2.29. Both univariate and multivariate linear regressions demonstrated a positive correlation between these scores. A multivariate Logistic regression analysis, using MKI as the independent variable and SCD-I criteria classification as the dependent variable, revealed a significant positive association. A notable association exists between SCD and perimenopausal symptoms severity. This underscores the potential clinical importance of addressing perimenopausal symptoms to mitigate SCD risks in women. Further studies should focus on clarifying the causality between these factors.

Abstract PO2-19-02: NRG-BR009: Phase III Trial Evaluating Addition of Adjuvant Chemotherapy to Ovarian Function Suppression + Endocrine Therapy in Premenopausal Women with pN0-1, HR+/HER2- Breast Cancer and Oncotype Recurrence Score ≤25 (OFSET)

Abstract Background: Identifying pts with HR-positive/HER2-negative breast cancer (BC) who benefit from adjuvant chemotherapy (ACT) has been a major research focus over the past 20 years. Development and clinical application of genomic classifiers such as the 21-gene recurrence score (RS) has contributed to the biologic understanding of BC and has refined pt selection for ACT. The TAILORx and RxPONDER clinical trials demonstrated that RS identifies many postmenopausal pts with node-negative and node-positive BC and RS &amp;lt; 25, who do not benefit from the addition of ACT to endocrine therapy (ET). However, both trials also showed that certain subsets of premenopausal pts (node-negative/high clinical risk/RS 16-20, node-negative/RS 21-25, and node-positive/RS &amp;lt; 25) benefited from the addition of ACT to ET. Most premenopausal pts in these two trials did not receive ovarian function suppression (OFS) as part of their ET regimen. Given the observed benefit from OFS in high-risk premenopausal pts with HR-positive/HER2-negative BC in the SOFT and TEXT trials, many questioned whether all or part of the observed ACT benefit in the TAILORx/RxPONDER trials may have been the result of chemotherapy-induced OFS. To address this question, OFSET is a Phase III, multicenter clinical trial evaluating the addition of ACT to OFS+ET vs. OFS+ET alone. Methods: We hypothesize that the addition of ACT to OFS+ET is superior to OFS+ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early-stage BC pts with HR-positive/HER2-negative tumors, and a 21-gene RS between 16-25 (for pN0 pts) and 0-25 (for pN1 pts). Secondary objectives include invasive disease-free survival (IDFS), overall survival (OS), distant recurrence-free interval (DRFI), breast cancer-free interval (BCFI), and health-related quality of life (HRQOL). Eligible pts must be node-negative with RS 16-20 (plus high clinical risk), or RS 21-25, or have 1-3 positive nodes with RS &amp;lt; 25. Stratification is by nodal status/RS status (pN0 RS 16-25 vs pN1 RS 0-15 and pN1 RS 16-25), intent to receive CDK4/6 inhibitor (yes; no), and age (18-39 vs ≥40). Pts are randomized after surgery to either OFS+ET or ACT followed by OFS+ET. ET is an aromatase inhibitor per investigator discretion, but tamoxifen is allowed if pts do not tolerate the AI or if OFS is incomplete. Radiation therapy will be administered per investigator discretion according to protocol guidelines. The HRQOL sub-study will assess differences in severe menopausal symptoms, measured by the FACT ESS-19 score, between the arms, as well as increased pain severity (PROMIS) during ACT+OFS+ET compared to OFS+ET. Blood and tumor specimens will be collected for future research. The accrual of 3,960 pts is anticipated to be completed in seven years and seven mos. Based on data from NSABP B-28 and RxPONDER, the 5-year IBCFS of pN1 pts on the ACT+OFS+ET arm is estimated at 92.3%. Based on data from TAILORx, the 5-year IBCFS of pN0 pts on the ACT arm is ~95%. Assuming 56% of the pts to be pN0 and 44% pN1, a 0.5% annual loss-to-follow-up rate, the definitive analyses to detect a hazard ratio: 0.75 with ACT+OFS+ET vs. OFS+ET, with one-sided alpha of 0.025 and 80% power will require 380 IBCFS events, which are expected to occur ~11 years after study initiation. The OFSET study is expected to be activated in the third quarter of 2023. Current accrual (06-19-2023) is 0/3,960 Support: U10CA180868, U10CA180822, UG1CA189867, U24CA196067. NCT05879926. Citation Format: Eleftherios Mamounas, Gong Tang, Shannon Puhalla, Sandra Swain, Patricia Ganz, N. Lynn Henry, Reena Cecchini, Sonya Reid, Priya Rastogi, Charles Geyer, Julia White, Amy Clark, Tufia Haddad, Gregory Vidal, Norman Wolmark. NRG-BR009: Phase III Trial Evaluating Addition of Adjuvant Chemotherapy to Ovarian Function Suppression + Endocrine Therapy in Premenopausal Women with pN0-1, HR+/HER2- Breast Cancer and Oncotype Recurrence Score ≤25 (OFSET) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-19-02.

The association of sociodemographic factors and history of chronic diseases on menopausal symptoms: A cross-sectional study.

Menopausal symptoms are very diverse in terms of prevalence and severity, and this difference is due to various factors such as psychological factors, sociocultural status, lifestyle, geographical location, and other factors. This study aimed to assess the prevalence of menopausal symptoms and evaluate the predictive factors related to the prevalence and severity of menopausal symptoms. This was a cross-sectional analytical study that was performed on 214 women aged 35-65 years old who were referred to Alzahra Educational, Research and Treatment Center in Rasht, Iran. The data collection tool was a valid and reliable questionnaire, using the list of menopausal symptoms and a checklist of subjects' general characteristics. 16.8% of postmenopausal women in our study had at least one menopausal symptom. Using multiple linear regression, race (p = 0.02), history of chronic diseases (p = 0.04), place of residence (p = 0.02), and marital satisfaction (p = 0.02) were associated with menopausal symptoms. Nineteen percentof the covariates related to the logistics function were explained by the predictor variables in the model. Evaluation of menopausal symptoms showed that the severity of menopausal symptoms was related to factors such as body mass index(BMI), ethnicity, place of residence, marital satisfaction, and history of chronic diseases, and need to address BMI, psychological issues, and chronic illness.

Severity and frequency of menopausal hot flash symptoms are not associated with arterial stiffness in females

Background: Females who experience menopausal hot flashes ([MHF]; episodes of sudden warmth and sweating) have greater risk of developing hypertension than females without MHF. MHF symptom severity and frequency are positively associated with hypertension. Considering that augmented arterial stiffness contributes to hypertension, this work aimed to investigate the relations between MHF severity and frequency with arterial stiffness. We hypothesized that females with moderate to severe MHF symptoms would exhibit greater arterial stiffness compared to females without MHF symptoms. Further, we hypothesized that there would be a positive relation between MHF frequency and arterial stiffness. Methods: Twenty-five females (51±5 [SD] years) with no history of hypertension or cardiovascular disease participated. The Menopausal Rating Scale was used to categorize participants by symptom severity (None MHF: n=7, Mild MHF: n=9, Moderate/Severe MHF: n=9). Participants self-reported MHF frequency over three consecutive days in real time using a hot flash diary (4±5 MHF/day, Range: 0-16). After 15 minutes of supine rest, brachial cuff blood pressures (sphygmomanometer) and heart rate (electrocardiogram) were recorded. Arterial stiffness was measured as pulse wave velocity ([PWV]; SphygmoCor®). PWV was measured using a carotid tonometer simultaneously with a leg cuff to capture blood pressure waveforms at the carotid and femoral sites. Aortic systolic pressure, aortic diastolic pressure, and augmentation index (AIx) were measured via pulse wave analysis ([PWA]; SphygmoCor®) using a brachial cuff. Data were analyzed using one-way analysis of variance (ANOVA) and Spearman Rho (ρ). Results: Age, body mass index, resting mean blood pressure, and resting heart rate were not different among MHF severity groups (P&gt;0.05 for all). PWV was not different among severity groups (None: 6.2±0.67 vs. Mild: 6.4±1.0 vs. Moderate/Severe: 6.6±1.0 cm/s, P=0.72). MHF frequency did not correlate with PWV (P=0.42). Aortic systolic pressure (None: 110±6 vs. Mild: 114±5 vs. Moderate/Severe: 112±11 mmHg, P=0.66), aortic diastolic pressure (None: 76±9 vs. Mild: 77±6 vs. Moderate/Severe: 76±10 mmHg, P=0.93), and AIx (None: 31.9±9.0 vs. Mild: 38.7±11.1 vs. Moderate/Severe: 30.4±7.4 %, P=0.16) were not different among severity groups. MHF frequency did not correlate with metrics of PWA (Systolic: P=0.61; Diastolic: P=0.89, AIx: P=0.42). Conclusion: Arterial stiffness and metrics of PWA were not different among females with varying MHF symptom severity. MHF frequency was also not correlated with aortic stiffness and metrics of PWA. Other mechanisms of vascular function (e.g., autonomic function, vasodilation, and/or vasoconstriction) should be investigated to determine potential contributors of hypertension risk in females with MHF. AHA 898649, NIH T32 DK07352, K01 HL148144, NCATS UL1 TR002377. This is the full abstract presented at the American Physiology Summit 2024 meeting and is only available in HTML format. There are no additional versions or additional content available for this abstract. Physiology was not involved in the peer review process.