Severity Of Fatigue In Patients Research Articles

Effect of Mediterranean diet on body mass index and fatigue severity in patients with multiple sclerosis: A systematic review and meta-analysis of clinical trials

BackgroundRecent studies imply that Mediterranean Diet (MeD) may play an important role in the management of Multiple Sclerosis (MS). This meta-analysis aimed to evaluate the effectiveness of MeD in addressing MS-related complications. MethodsA thorough search was performed in MEDLINE (PubMed), Scopus, EMBASE, ScienceDirect, Google Scholar, Web of Science, and the Central Cochrane Library, covering trials published until September 2023. The quantitative data were synthesized using random effect models through STATA14. ResultsAfter analyzing 228 entries, we found five Randomized Controlled Trials (RCTs) with a total of 540 participants, who had an average disease duration of 8.5 years. The combined effect size revealed a decrease in Body Mass Index (BMI) (Weighted Mean Difference [WMD] = −0.88 kg/m2; 95 % Confidence Interval [CI] = −1.68, −0.08; P = 0.030). There was also a non-significant marginal improvement in fatigue severity (WMD = −8.29; 95 % CI = −16.74, 0.16; P = 0.054). ConclusionAdherence to MeD may improve BMI and fatigue severity in MS patients. Further RCTs are needed to confirm the current results.

Fatigue in patients with hypothalamic syndrome – A cross-sectional analysis of the German childhood-onset craniopharyngioma cohort

ObjectivePatients with suprasellar tumors are at risk for hypothalamic syndrome (HS), including fatigue and excessive daytime sleepiness. The aim of this cross-sectional study was to determine the severity of fatigue in patients with and without HS. MethodsPatients diagnosed with CP or pilocytic astrocytoma were recruited from the KRANIOPHARYNGEOM studies. Eligibility criteria were availability of one completed Multidimensional Fatigue Inventory-20 (MFI-20) questionnaire and complete medical records on criteria for HS. The associations between HS and levels of fatigue symptoms (MFI-20 sum score) were assessed. MFI-20 scores were compared to sex- and age-matched reference values from a German normative population. ResultsData on 41 patients, with a median age of 22 years, were available for analyses of which 25 (61 %) patients presented with HS. After adjustment for age and sex, patients with HS reported higher scores in the physical (β= 3.39 [95 %-CI:1.18–5.60]) and sum MFI-20 (β=11.42 [95 %-CI:2.06–20.79]) domain than patients without HS. Compared to reference values, all patients reported higher mean scores in each fatigue domain. Abnormal self-reported daytime sleepiness was reported in 6 of 25 (24 %) patients with HS. Regardless of the level of daytime sleepiness in patients with HS, the reported fatigue scores were high. Daytime sleepiness did not correlate with fatigue. ConclusionsFatigue symptoms are present in patients with CP. However, patients with HS are more affected with physical and overall fatigue. It is crucial in clinical practice, to distinguish between daytime sleepiness and fatigue and to target patients with HS.

CP-01. FATIGUE IN PATIENTS WITH HYPOTHALAMIC SYNDROME – A CROSS-SECTIONAL ANALYSIS IN THE GERMAN CHILDHOOD-ONSET CRANIOPHARYNGIOMA COHORT

Abstract BACKGROUND Patients with tumors of the sellar region are at risk of developing hypothalamic syndrome. Survivors experience fatigue and excessive daytime sleepiness even years after tumor treatment. The aim of this cross-sectional study was to determine the severity of fatigue in patients with and without hypothalamic syndrome. METHODS Patients diagnosed with CP or pilocytic astrocytoma were recruited from the KRANIOPHARYNGEOM 2000/2007/Registry 2019 studies and included in this analysis. Eligibility criteria were regular participation in outpatient after-care, one completed Multidimensional Fatigue Inventory-20 (MFI-20) questionnaire and complete medical records on criteria for hypothalamic syndrome. With univariable and multivariable linear regression, the relation of hypothalamic syndrome and levels of fatigue symptoms (MFI-20 sum score) were assessed. MFI-20 scores were compared to sex- and age-matched reference values from a German normative population using paired t-test. RESULTS Data on 46 patients, with a median age of 20 years, was available for this analysis of which 28 (61%) patients presented with hypothalamic syndrome. After adjustment for age and sex, patients with hypothalamic syndrome reported higher scores in the physical (= 3.61 [95% CI: 1.38–5.85]), mental (= 2.80 [95% CI: 0.28–5.32]) and sum MFI-20 (= 12.02 [95% CI: 2.93–21.10]) domain than patients without hypothalamic syndrome. Compared to reference values from a general German population, all patients reported higher mean scores in each fatigue domain. Regardless of the level of daytime sleepiness in patients with hypothalamic syndrome, the reported fatigue scores were high. Daytime sleepiness did not correlate with fatigue. CONCLUSIONS Fatigue symptoms are present in patients with CP. However, patients with hypothalamic syndrome are more affected in mental, physical and overall fatigue. It is crucial in clinical practice, to distinguish between sleep disorders and fatigue and to target patients with hypothalamic syndrome.

Assessing the Relationship between Dietary Phytochemical Index and Fatigue Severity in Multiple Sclerosis Patients

Background: Phytochemical-rich foods have anti-inflammatory effects and play a role in the prevention and control of inflammatory diseases such as Multiple Sclerosis (MS). Although some aspects of a diet high in phytochemicals promoting health and preventing chronic diseases are known, further studies are required to confirm the previous findings. Methods: This cross-sectional study investigated the relationship between Dietary Phytochemical Index (DPI) and fatigue severity in patients with MS. A total of 240 patients aged 18 to 65 years were selected from the MS Association center of Golestan province. A valid and reliable food frequency questionnaire was used to evaluate the diet, and fatigue severity was assessed using the Fatigue Severity Scale (FSS) questionnaire. DPI was calculated using the formula [daily energy from foods rich in phytochemicals (kcal) divided by total daily energy intake (kcal)] and was calculated as 100. Results: After controlling for potential confounding factors, the highest tertile of DPI had a lower prevalence of fatigue symptoms (odds ratio (OR: 0.27; 95%CI: 0.03-0.36; p=0.012) compared to those in the lowest tertile. The average age of the study participants was 31.9±7.7 years, and the fatigue score scale among the participants was 39.31±11.62. Conclusion: In conclusion, a significant inverse relationship between DPI and fatigue severity was observed in patients with MS. Further prospective studies are needed to confirm these findings.

Systematic review of fatigue severity in ME/CFS patients: insights from randomized controlled trials

BackgroundMyalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a debilitating illness medically unexplained, affecting approximately 1% of the global population. Due to the subjective complaint, assessing the exact severity of fatigue is a clinical challenge, thus, this study aimed to produce comprehensive features of fatigue severity in ME/CFS patients.MethodsWe systematically extracted the data for fatigue levels of participants in randomized controlled trials (RCTs) targeting ME/CFS from PubMed, Cochrane Library, Web of Science, and CINAHL throughout January 31, 2024. We normalized each different measurement to a maximum 100-point scale and performed a meta-analysis to assess fatigue severity by subgroups of age, fatigue domain, intervention, case definition, and assessment tool, respectively.ResultsAmong the total of 497 relevant studies, 60 RCTs finally met our eligibility criteria, which included a total of 7088 ME/CFS patients (males 1815, females 4532, and no information 741). The fatigue severity of the whole 7,088 patients was 77.9 (95% CI 74.7–81.0), showing 77.7 (95% CI 74.3–81.0) from 54 RCTs in 6,706 adults and 79.6 (95% CI 69.8–89.3) from 6 RCTs in 382 adolescents. Regarding the domain of fatigue, ‘cognitive’ (74.2, 95% CI 65.4–83.0) and ‘physical’ fatigue (74.3, 95% CI 68.3–80.3) were a little higher than ‘mental’ fatigue (70.1, 95% CI 64.4–75.8). The ME/CFS participants for non-pharmacological intervention (79.1, 95% CI 75.2–83.0) showed a higher fatigue level than those for pharmacological intervention (75.5, 95% CI 70.0–81.0). The fatigue levels of ME/CFS patients varied according to diagnostic criteria and assessment tools adapted in RCTs, likely from 54.2 by ICC (International Consensus Criteria) to 83.6 by Canadian criteria and 54.2 by MFS (Mental Fatigue Scale) to 88.6 by CIS (Checklist Individual Strength), respectively.ConclusionsThis systematic review firstly produced comprehensive features of fatigue severity in patients with ME/CFS. Our data will provide insights for clinicians in diagnosis, therapeutic assessment, and patient management, as well as for researchers in fatigue-related investigations.

Structural relations of illness perception, fatigue, locus of control, self-efficacy, and coping strategies in patients with multiple sclerosis: a cross-sectional study

BackgroundPatients with multiple sclerosis (MS) experience extensive problems due to fatigue and illness perception. Reducing these problems may improve these patients’ quality of life (QoL). Accordingly, the current study is aimed at investigating the mediating role of self-efficacy, locus of control, coping strategy, and outcome expectancy in the relationship between illness perception and fatigue severity in patients with MS.MethodsIn a cross-sectional analytical study, data of 172 MS patients were collected by self-report questionnaires including illness perception questionnaires (IPQ-R), Multiple Sclerosis Self-Efficacy (MSSES) scale, health locus of control (MHLC), coping strategies in MS(CMSS), outcome expectancy, level of physical activity (IPAQ-SF), patient activation measure (PAM-13) and fatigue severity scale (FSS). The data were analyzed using linear and multiple regression analysis in SPSS software version 24 (SPSS Inc., Chicago, IL, USA).ResultsThe final model explained 62% of the fatigue variance. Illness perception both directly and indirectly (through self-efficacy, physical activity level, internal health locus of control, patient activation, and negative coping strategies) could predict the participants’ fatigue severity. Among the mediating variables, internal health locus of control, self-efficacy, and negative coping strategies had the greatest impact, respectively. moreover, outcome expectancy variable did not a mediating role in the aforementioned relationship.ConclusionsTo enhance the well-being of MS patients and to improve the efficiency of treating MS related fatigue, a comprehensive treatment protocol is needed, encompassing psychological factors affecting fatigue severity.

Prevalence and risk factors of depression among patients with perianal fistulizing Crohn's disease.

Psychological distress, especially depression, associated with perianal fistulizing Crohn's disease (PFCD) is widespread and refractory. However, there is a surprising paucity of studies to date that have sought to identify the prevalence and risk factors of depression associated with PFCD. To estimate the prevalence of depressive symptoms and investigate the depression-related risk factors in patients with PFCD. The study was conducted in the form of survey and clinical data collection via questionnaire and specialized medical staff. Depressive symptoms, life quality, and fatigue severity of patients with PFCD were assessed by Patient Health Questionnaire-9, Inflammatory Bowel Disease Patient Quality of Life Questionnaire (IBDQ), and Inflammatory Bowel Disease (IBD) Fatigue Patient Self-assessment Scale. The basic demographic information, overall disease features, perianal clinical information, and laboratory inflammation indicators were also gathered. Multivariate regression analysis was ultimately used to ascertain the risk factors of depression associated with PFCD. A total of 123 patients with PFCD were involved, and 56.91% were suffering from depression. According to multivariate logistic regression analysis, Perianal Disease Activity Index (PDAI) score [odds ratio (OR) = 0.69, 95% confidence interval (CI): 0.50 to 0.95], IBDQ score (OR = 0.93, 95%CI: 0.88 to 0.97), modified Van Assche index (OR = 1.24, 95%CI: 1.01 to 1.53), and IBD Fatigue score (OR = 1.72, 95%CI: 1.23 to 2.42) were independent risk factors of depression-related prevalence among patients with PFCD (P < 0.05). Multiple linear regression analysis revealed that the increasing perianal modified Van Assche index (β value = 0.166, 95%CI: 0.02 to 0.31) and decreasing IBDQ score (β value = -0.116, 95%CI: -0.14 to -0.09) were independently associated with the severity of depression (P < 0.05). Depressive symptoms in PFCD patients have significantly high prevalence. PDAI score, modified Van Assche index, quality of life, and fatigue severity were the main independent risk factors.

Investigation of the effects of cocoa powder on fatigue severity in patients with relapsing-remitting multiple sclerosis: A randomized controlled trial

Investigation of the effects of cocoa powder on fatigue severity in patients with relapsing-remitting multiple sclerosis: A randomized controlled trial

Effects of Modified Stretching Exercises on Fatigue Intensity in Patients with Type 2 Diabetes: A Randomized Clinical Trial

Background: Patients with type 2 diabetes suffer from fatigue and disease complications. Exercise is one of the non-medicinal methods, which is also affordable and can be done at any time and place. Objectives: This study aimed to determine the effects of modified stretching exercise on fatigue intensity in patients with type 2 diabetes. Methods: In the present clinical trial study, the research population consisted of all patients with type 2 diabetes in the internal clinic of Shahid Fayaz-Bakhsh Hospital, Tehran, in 2021. A total number of 50 eligible patients with type 2 diabetes were selected by non-randomized sampling method. The selected participants were randomly divided into two groups: Experiment (25 people) and control (25 people). In the experimental group, training was held in 12 sessions. A demographic checklist and the Multidimensional Fatigue Inventory (MFI) were used to collect data before and after the intervention. The collected data were analyzed through descriptive statistics and paired t-test, chi-square, and independent t-test. Results: Before the intervention, there was no statistically significant difference in the overall scores of fatigue and its dimensions between the experimental and control groups (P &gt; 0.05). After completing the interventions, a statistically significant difference was observed in the mean scores of fatigue and its dimensions between the experimental and control groups (P &lt; 0.001). Conclusions: Modified stretching exercises can improve the severity of fatigue in patients with type 2 diabetes. We suggest that healthcare providers use this stretching exercise to improve fatigue in diabetic patients.

Psychometric properties of the Fatigue Catastrophizing Scale in a general population and its clinical utility in schizophrenia and breast cancer patients

ABSTRACTObjectiveFatigue catastrophizing is the tendency to engage in negative thinking and evaluative patterns toward experienced fatigue. A number of studies consistently support the significant role of fatigue catastrophizing in perpetuating symptoms of fatigue but no tool has yet been validated. This study aimed to: (1) investigate the psychometric properties of the fatigue catastrophizing scale (FCS) in a sample of non-clinical adults; (2) explore the contribution of catastrophizing to overall fatigue severity in non-clinical participants and in two clinical populations with high fatigue prevalence rates (schizophrenia and breast cancer).MethodsData were collected from 389 French-speaking adults, including 301 non-clinical participants, 30 individuals with schizophrenia, and 58 individuals with a diagnosis of breast cancer. All participants completed the FCS and other questionnaires to assess convergent and divergent validities. Psychometric properties of the FCS were investigated including its factor structure, internal consistency, test–retest reliability and convergent validities. Hierarchical linear regressions were conducted to investigate whether catastrophizing contributed to fatigue severity in the different groups.ResultsExploratory and confirmatory factor analyzes revealed a two-factor structure, helplessness/magnification and rumination. Moreover, analyzes demonstrated high internal consistency, good convergent and divergent validities, and excellent temporal stability. Overall, fatigue catastrophizing significantly contributed to the variance of fatigue severity in patients with breast cancer and in patients with schizophrenia.ConclusionThe French version of the fatigue catastrophizing scale has good psychometric properties. Fatigue catastrophizing may be clinically important in individuals with a fatigue complaint. Psychological interventions targeting fatigue catastrophizing are warranted in the two clinical populations.

The association of serum carnitine levels with severity of fatigue in patients with multiple sclerosis: A pilot study.

Background: Fatigue is a common complaint of patients with multiple sclerosis (MS), adversely affecting their quality of life. There is a lot of evidence showing that carnitine deficiency is linked to fatigue development and severity in some conditions. This study aimed to evaluate the association between free L-carnitine serum levels and the severity of fatigue in patients with MS. Methods: This case-control study included 30 patients with relapsing-remitting MS (RRMS) in two age-matched equal-number groups according to the presence or absence of fatigue. Fatigue was scored using the valid questionnaire of Fatigue Severity Scale (FSS) and serum level of free L-carnitine was measured simultaneously. Finally, the association between serum level of free L-carnitine and fatigue severity was evaluated in patients with MS. Results: The mean value of FSS in patients with fatigue was 48.80 ± 8.55, which was nearly two-fold higher than the group without fatigue. We found a significant correlation between the serum level of free L-carnitine and FSS and showed that the patients with fatigue had a significantly lower serum level of free L-carnitine compared to patients without fatigue (P < 0.001). Conclusion: Present study demonstrated that patients with lower serum levels of free L-carnitine were more likely to experience fatigue. We recommend that a higher dietary intake of carnitine might be a useful complementary treatment for MS-related fatigue.

Decreased Serum Neurofilament Light Chain and Fatigue Severity in Patients with Multiple Sclerosis after Home-Based and Outdoor Pilates Training

Decreased Serum Neurofilament Light Chain and Fatigue Severity in Patients with Multiple Sclerosis after Home-Based and Outdoor Pilates Training

The Effect of a Combined Exercise Program on the Fatigue Severity of Patients with Breast Cancer Undergoing Chemotherapy: A Randomized Clinical Trial Study.

Breast Cancer (BC) is one of the most common cancers in the world, including in Iran. Chemotherapy as one of the basic treatments for BC leads to many side effects such as fatigue. This study aimed to examine the effect of a combined exercise program on the intensity of fatigue in patients with BC undergoing chemotherapy. This clinical trial study was conducted on 64 patients with BC undergoing chemotherapy referring to the Seyyed al-Shoada and the Al-Zahra clinics from January to April 2022. Eligible patients who met inclusion criteria were recruited by the convenience sampling and then assigned randomly to intervention and control groups. The combined exercise program in the intervention group was done for 8 weeks as three sessions a week (34 sessions) each for 35-40 min. Piper's Fatigue Scale was completed for both groups before and after the intervention. Data were analyzed using descriptive and inferential statistical methods. The results showed that the mean score of fatigue intensity in both control and intervention groups had a statistically significant difference after the intervention (p = 0.004). The mean fatigue intensity score in the intervention group decreased significantly from mean (SD) 8.17 (1.88) to 5.56 (1.74). Based on the results, a combined exercise program can reduce fatigue in patients with BC. Therefore, nurses can utilize exercise programs and practices as a subset of complementary medicine alongside other treatment methods, which can effectively promote cancer patients' quality of life by reducing their fatigue.

P174 Uncontrolled depression and female gender increase the risk of severe fatigue in patients with inflammatory bowel disease under infliximab therapy.

Abstract Background Fatigue is a significant predictor of worst health-related qualify of life in inflammatory bowel disease (IBD) patients. Nevertheless, the role of fatigue in IBD patients under infliximab (IFX) therapy has been poorly investigated. The aim of the study was to evaluate the potential factors associated with fatigue in patients under maintenance treatment with IFX. Methods A prospective observational cohort study was designed. All IBD patients aged 18 and over under maintenance treatment with intravenous (IV) infliximab were consecutively included at the infusion day. Patients completed 3 self administered questionnaires. Fatigue was assessed with the Fatigue Impact Scale (FIS), quality of life with the Inflammatory Bowel Disease Questionnaire-Short From (IBDQ-9) and anxiety and depression using the Hospital Anxiety and Depression scale (HAD). We considered the maximum total FIS as the highest fatigue perception. Disease activity was defined in Crohn’s disease as a Harvey-Bradshaw index &amp;gt;4, and in ulcerative colitis (UC) as a Partial Mayo index &amp;gt;2. Patient demographics and disease characteristics were also collected: age, sex, disease duration, smoking habit, type of IBD, extra-intestinal manifestations, clinical activity, prior surgery, obesity, anemia, treatments (steroids, immunosuppressants, anxiolytics, antidepressants) and presence of anxiety or depression. Multiple linear regression was used to identify the variables associated with the presence of fatigue. Results Ninety patients were consecutively included (49 female, median age 42 years, interquartile range 19). Sixty three patients (70%) had Crohn’s disease (46.8% fistulising and 25.8% stenosing behaviour) and twenty seven ulcerative colitis (30%). Nearly 27% were smokers, 35 (39%) presented anxiety and 18 (21%) depression. Approximately, 8% of the patients and 7% received treatment for anxiety and depression, respectively, but only 2/18 patients with current depression received antidepressants. Combotherapy was present in 41% of the patients and 75.6% were in clinical remission. Mean fatigue was 32.74 ± SD 17.27. The highest scores for fatigue were associated with female gender (B = 10.936; P= 0.009) and the presence of depression (B = 11.114; P = 0.029). Activity disease almost increased significantly the severity of the fatigue(B = 8.995; P= 0.063). The use of antidepressants not increased the risk (B = -4.995; P = 0.555). Patients with fatigue had significantly reduced the quality of life (r = -0.638; p &amp;lt; 0.001) (Figure 1). Conclusion Uncontrolled depression and female gender increased the risk of severe fatigue more than disease activity in patients under maintenance treatment with IFX. Fatigue is related to worst health-related qualify of life.

Effects of Almond Porridge, Grape Extract, and Pea Syrup on Fatigue Severity of Patients with COVID-19

Effects of Almond Porridge, Grape Extract, and Pea Syrup on Fatigue Severity of Patients with COVID-19

Moderating Effect Of Gender-Based Differences On Physical Activity And Fatigue Among Recovered COVID-19 Patients

PURPOSE: Clinical data point toward gender-based differences in COVID-19 severity. However, there is insufficient research examining whether gender differences predict physical activity (PA) and fatigue severity in patients recovering from COVID-19. Therefore, this study aimed to characterize the PA and fatigue severity in a cohort of patients recovering from COVID-19 and measure the extent to which gender-based differences moderate the relationship of PA with fatigue. METHODS: A cross-sectional study was conducted. The sample comprised patients recovering from COVID-19 over at least 3 months. Recovered patients were stratified into two groups based on gender. The survey included items pertaining to sociodemographic, a fatigue severity scale (FSS) and a self-reported international PA questionnaire (IPAQ). Mann-Whitney U tests were conducted in analysis. To assess the moderating effect of gender in this research, a simple moderator regression analysis was done using the PROCESS macro, version 3.5.3. The data were analyzed using statistical software. RESULTS: Eighty-seven patients (44 women and 43 men) met the inclusion criteria. Compared with men, most women were more likely to report sedentary behavior (70%) and high fatigue severity (64%). A significantly higher number of women had a low PA score on the IPAQ compared with men (p = .002). Compared with men, there was a significant difference in the proportions of women who had greater fatigue (p = .001). The results of multiple linear regression analyses for the association between gender and total METs of PA and fatigue severity as dependent variables showed that the gender is considered a significant independent predictor of total PA and fatigue severity (R2 = .17, p = .003; R2 = .34, p = .002), respectively. Gender moderates the relationship between self-perceived fatigue and total PA (= .001, SE = .006, p = .03), which suggests that gender is a moderator of the effect of total PA on fatigue severity. CONCLUSION: the current study illustrated the incidence of lower levels of PA and a higher FSS result in women who had recovered from COVID-19. Considering the importance of increasing PA levels and decreasing fatigue levels, longitudinal studies to encourage PA engagement among female and to control fatigue are recommended.

Patient self-reporting of tolerability using PRO-CTCAE in a randomized double-blind, placebo-controlled phase II trial comparing gemcitabine in combination with adavosertib or placebo in patients with platinum resistant or refractory epithelial ovarian carcinoma

BackgroundA double-blind, randomized, placebo-controlled, phase 2 trial assessed gemcitabine in combination with the wee1 inhibitor adavosertib or placebo in platinum resistant or refractory high grade serous ovarian cancer (HGSOC), demonstrating improved progression free and overall survival favouring the adavosertib/gemcitabine arm. An exploratory objective of the study included the PRO-CTCAE assessment, to capture self-reporting of frequency, severity and/or interference of symptomatic adverse events (syAEs). MethodsPRO-CTCAE items at baseline, days 1 and 15 of each cycle and off treatment, were completed in two centres, with the objective of characterizing syAEs in the first three months of therapy. The maximum post-baseline score proportion for each syAE was tabulated per patient. The 12-week area under the curve (AUC12w) as a measure of syAE over-time and incremental AUC12w (iAUC12w) for adjustment to baseline syAEs. ResultsSixty-one patients were approached for PRO-CTCAE surveys and 55 were evaluable. Among patients with HGSOC, 28 received gemcitabine/adavosertib (arm A) and 19 gemcitabine/placebo (arm B). Survey completion rates were high. The proportion of participants with positive (≥1) PRO-CTCAE scores was higher for difficulty swallowing with gemcitabine/adavosertib (arm A 35.7% vs arm B 5.3%, p = 0.02). The high score (≥3) syAEs showed more frequent diarrhea with gemcitabine/adavosertib (arm A 25% vs arm B 0%, p = 0.03). The proportions of worsening syAEs over time were higher in patients receiving gemcitabine/adavosertib for difficulty swallowing (arm A 35.7% vs arm B 5.3%; p = 0.03) and fatigue severity (arm A 71.43% vs arm B 42.1%; p = 0.04). ConclusionsThe longitudinal assessment of patient self-reported tolerability showed greater difficulty swallowing and fatigue severity in patients receiving gemcitabine/adavosertib, compared to gemcitabine/placebo. PRO-CTCAE provides complementary and objective assessment of drug tolerability from a patient's perspective.

Effect of Rosa damascena Oil Aromatherapy on Fatigue Severity in Patients Receiving Hemodialysis: A Randomized Controlled Trial

Objectives: The prevalence of fatigue in patients receiving hemodialysis is high. This study aimed to investigate the effect of Rosa damascena oil on fatigue severity in patients receiving hemodialysis. Materials and Methods: This randomized controlled trial was performed on 74 patients receiving hemodialysis in Tabriz, Iran from January 21 to February 21, 2019. The patients were conveniently recruited and assigned into two groups of intervention and control using a block randomization method with block sizes of four and six and a sequence of 1:1. Patients in the intervention group were trained to inhale three drops of R. damascena oil each night for one month. We used the Fatigue Severity Scale (FSS) for data collection and analyzed the data using the independent samples and paired t tests. Results: No significant difference was found between the two groups respecting the mean baseline fatigue scores (P=0.12). However, at the end of the study, the mean fatigue score was significantly lower in the intervention group compared to the control group (P=0.001). Conclusions: We witnessed that R. damascena oil aromatherapy significantly reduced the severity of fatigue in patients receiving hemodialysis. This useful and inexpensive technique can be utilized as a complementary method to relieve fatigue in patients receiving hemodialysis.

Reducing severe fatigue in patients with diffuse glioma: a study protocol for an RCT on the effect of blended cognitive behavioural therapy

BackgroundFatigue is the most frequent and burdensome symptom of patients with diffuse glioma. It is closely linked to decreased health-related quality of life and symptoms such as depression and sleep disturbances. Currently, there is no evidence-based treatment that targets severe fatigue in patients with brain tumours. Cognitive behavioural therapy is aimed at fatigue-maintaining beliefs and behaviour. This therapy has been proven effective in reducing severe fatigue in cancer survivors and patients with multiple sclerosis. A blended therapy program combines sessions with a therapist with therapist-guided web-based therapy modules. The aim of this randomized controlled trial is to determine the efficacy of blended cognitive behavioural therapy in treating severe fatigue in patients with diffuse glioma.MethodsWe will include a maximum of 100 patients with diffuse glioma with clinically and radiologically stable disease and severe fatigue (i.e. Checklist Individual Strength, subscale fatigue severity ≥ 35). Patients will be randomized to blended cognitive behavioural therapy or a waiting list condition. The 12-week intervention GRIP on fatigue consists of five patient-therapist sessions and five to eight individualized web-based therapy modules supported by email contact. The primary outcome measure is fatigue severity. Secondary outcome measures include sleep quality, health-related quality of life, depression, anxiety, functional impairment and subjective and objective cognitive functioning. Primary and secondary outcome measures will be assessed at baseline and after 14 and 24 weeks. Magnetoencephalography and MRI will be used to evaluate potential biomarkers for intervention success. This trial has a Bayesian design: we will conduct multiple interim analyses to test for efficacy or futility of the trial. This is the first trial within the GRIP trial platform: a platform developing four to five different interventions for the most common symptoms in patients with diffuse glioma.DiscussionThe results of the GRIP on fatigue trial will provide information about the efficacy of this intervention on fatigue in patients with diffuse glioma. Multiple other outcomes and possible predictors of treatment success will also be explored.Trial registrationNetherlands Trial Register NL8711. Registered on 14 June 2020.

A pilot study of the moderating effect of gender on the physical activity and fatigue severity among recovered COVID-19 patients.

BackgroundClinical data point toward gender-based differences in COVID-19 severity. However, there is insufficient research examining whether gender predicts physical activity (PA) and fatigue severity in patients recovering from COVID-19. Therefore, this study aimed to characterize the PA and fatigue severity in a cohort of patients recovering from COVID-19 infection and measure the extent to which gender-based differences moderate the relationship of PA with fatigue.MethodA cross-sectional survey was conducted in Riyadh, Saudi Arabia. The sample comprised patients recovering from COVID-19 over at least 3 months. Recovered patients were stratified into two groups based on gender. The survey included items pertaining to sociodemographic, a fatigue severity scale and a self-reported international PA questionnaire.ResultsEighty-seven patients (44 women and 43 men) met the inclusion criteria. Compared with men, women reported sedentary behavior (70%) and high fatigue severity (64%). A significantly higher number of women had a low PA score compared with men (p = .002). The findings indicated that gender significantly moderates the effect of total PA in metabolic equivalents (METs; min/wk) on fatigue severity [F = 4.8, p = .03, ΔR2 = 0.24].ConclusionsThe current study suggests that women might be at risk of higher fatigue severity, in addition to engaging less in PA. Physical activity may plays a significant role in modulate the fatigue severity. Consequently, interventions aimed at promoting physical activity in women stand high chances of addressing the disparity in the distribution of prevalence of fatigue between men and women.