Fatigue Assessment Scale Score Research Articles

Circulating Mitochondrial DNA Is Associated With High Levels of Fatigue in Two Independent Sarcoidosis Cohorts

Patients with sarcoidosis who develop severe clinical phenotypes of pulmonary fibrosis or multiorgan disease experience debilitating symptoms, with fatigue being a common chief complaint. Studies that have investigated this patient-related outcome measure (PROM) have used the Fatigue Assessment Scale (FAS), a self-reported questionnaire that reflects mental and physical domains. Despite extensive work, its cause is unknown and treatment options remain limited. Previously, we showed that the plasma of patients with sarcoidosis with extrapulmonary disease endorsing fatigue was enriched for mitochondrial DNA (mtDNA), a ligand for the innate immune receptor toll-like receptor 9 (TLR9). Through our cross-disciplinary platform, we investigated a relationship between sarcoidosis-induced fatigue and circulating mtDNA. Is there a psychobiologic mechanism that connects sarcoidosis-induced fatigue and mtDNA-mediated TLR9 activation? Using a local cohort of patients at Yale (discovery cohort) and the National Institutes of Health-sponsored Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis study (validation cohort), we scored the FAS and quantified in the plasma, mtDNA concentrations, TLR9 activation, and cytokine levels. Although FAS scores were independent of corticosteroid use and Scadding stage, we observed a robust association between FAS scores, which included mental and physical domains, and multiorgan sarcoidosis. Subsequently, we identified a significant correlation between plasma mtDNA concentrations and all domains of fatigue. Additionally, we found that TLR9 activation is associated with all aspects of the FAS and partially mediates this PROM through mtDNA. Last, we found that TLR9-associated soluble mediators in the plasma are independent of all facets of fatigue. Through our cross-disciplinary translational platform, we identified a previously unrecognized psychobiologic connection between sarcoidosis-induced fatigue and circulating mtDNA concentrations. Mechanistic work that investigates the contribution of mtDNA-mediated innate immune activation in this PROM and clinical studies with prospective cohorts has the potential to catalyze novel therapeutic strategies for this patient population and those with similar conditions.

How long is Long-COVID? Symptomatic improvement between 12 and 18 months in a prospective cohort study

IntroductionCOVID-19 infection can precede, in a proportion of patients, a prolonged syndrome including fatigue, exercise intolerance, mood and cognitive problems. This study aimed to describe the profile of fatigue-related, exercise-related,...

The Mediating Role of Depression and of State Anxiety οn the Relationship between Trait Anxiety and Fatigue in Nurses during the Pandemic Crisis.

The coronavirus pandemic (COVID-19) is a global health crisis with a particular emotional and physical impact on health professionals, especially nurses. The aim of this study was to investigate the prevalence of anxiety, depression and fatigue and their possible relationships among nurses during the pandemic. The study population consisted of nurses from five tertiary-level public hospitals in Athens who completed the Fatigue Assessment Scale (FAS), Beck Depression Inventory (BDI) and State-Trait Anxiety Inventory (STAI) questionnaires. Gender, age and years of work experience were recorded. The study was conducted from mid-November to mid-December 2021. The sample included 404 nurses (69 males and 335 females) with a mean age of 42.88 years (SD = 10.90) and 17.96 (SD = 12.00) years of work experience. Symptoms of fatigue were noted in 60.4% of participants, while 39.7% had symptoms of depression, 60.1% had abnormal scores on state anxiety and 46.8% on trait anxiety, with females showing higher scores on all scales (p < 0.05). High positive correlations (p < 0.01) were found between the FAS, BDI, State Anxiety and Trait Anxiety scales. Regression analysis showed that 51.7% of the variance in FAS scores can be explained by trait anxiety, an additional 6.2% by the BDI and 1.2% by state anxiety. Mediation analysis showed that state anxiety and BDI mediate the relationship between trait anxiety and FAS. Finally, BDI was found to exert a moderating role in the relationship between trait anxiety and fatigue. In conclusion, our study showed that nurses continue to experience high rates of anxiety, depression and fatigue. The variation in fatigue appears to be significantly dependent on trait anxiety. Depressive symptomatology and state anxiety exert a parallel positive mediation on the relationship between trait anxiety and fatigue, with depression exhibiting a moderating role in this relationship.

Efficacy of potassium N-acetylaminosuccinate (Cogitum) in the treatment of asthenic syndrome: results of double-blind placebo-controlled trial

Study of the effectiveness of monotherapy with potassium N-acetylaminosuccinate (Cogitum) for asthenic syndrome (fatigue) in individuals, uncharacteristic somatic, neurological diseases, anxiety disorders, depression and other diseases that may interfere with asthenia. Patients with fatigue scores of 22 or more on the Fatigue Assessment Scale (FAS) were randomly divided into the main group (MG) - 37 people, mean age 22 years [21; 24] and the control group (CG) - 34 people, mean age 21 years [19; 23]. The Trail Making Test (TMT-A and TMT-B), the assessment of general well-being on a visual analogue scale (VAS), where 0 is the worst state of health, 10 is the state of absolute well-being, was assessed. MG patients received a solution of potassium N-acetylaminosuccinate (Cogitum) 750 mg per day in a sterile container, CG patients received sterile water with banana flavor in a sterile container. The duration of the study was 21 days. Prior to the start of the study, there were no statistically significant differences in FAS, TMT, and VAS between MG and CG. After 21 days, the FAS score in the MG decreased (p=0.00001), the time of TMT-A (p=0.000012) and TMT-B (p=0.000033) decreased, the VAS score increased (p=0.00024). There were no statistically significant changes in the CG. Placebo effect was noted in 10 patients of the CG (29.4%). Potassium aminosuccinate (Cogitum) at a daily dose of 750 mg and a duration of treatment of 21 days effectively eliminates the symptoms of asthenic syndrome (fatigue), while accompanied by an improvement in complex cognitive functions. The results of our study suggest that fatigue (asthenic syndrome) and cognitive impairment may have a common pathogenetic mechanism - a deficiency of systems in which mediators are N-acetylaspartate and N-acetylaspartylglutamate. Cogitum had no side effects and was well tolerated. Cogitum is superior to placebo in the treatment of fatigue (asthenic syndrome).

Online mindfulness-based cognitive therapy for fatigue in patients with sarcoidosis (TIRED): a randomised controlled trial

Sarcoidosis-associated fatigue is highly prevalent and is often reported as the most burdensome symptom of sarcoidosis. Management of fatigue is challenging, and evidence-based therapies are lacking. In this TIRED trial, we aimed to assess the effects of a 12-week online mindfulness-based cognitive therapy (eMBCT) on fatigue. This study was a prospective, open-label, multicentre randomised controlled trial, conducted at three centres in the Netherlands. Eligible patients were 18 years or older, had stable sarcoidosis, and a score of more than 21 points on the Fatigue Assessment Scale (FAS). Patients were randomised into either the eMBCT or the control group. Participants completed patient-reported outcome measures at baseline, after intervention (T1), and 12 weeks after completion of eMBCT (T2). The primary outcome was the change in FAS score at T1 in the eMBCT group compared with the control group, assessed with the independent students't test in all patients who started the study. Secondary outcomes included within-group difference in FAS score at T1 and T2, between-group difference in FAS score at T2, and changes in the Hospital Anxiety and Depression Scale, the Freiburg Mindfulness Inventory-Short Form, and the Kings Sarcoidosis Questionnaire. The study was registered at the Netherlands Trial Register, NL7816. Between June 5, 2019, and Oct 28, 2021, 99 patients were randomly assigned to the eMBCT (n=52) or the control (n=47) groups. Six patients withdrew consent after psychological screening before the start of eMBCT. Baseline FAS score was similar in both groups (34·57 [SD 6·07] for 46 patients in the eMBCT group and 35·51 [4·65] for 47 patients in the control group). Mean change in FAS score at T1 was -4·53 (SD 5·77; p<0·0001) in the eMBCT group and -1·28 (3·80; p=0·026) in the control group (between-group difference 3·26 [95% CI 1·18 to 5·33; p=0·0025]). Furthermore, the eMBCT group had a significant improvement in anxiety (mean between-group difference 1·69, 95% CI 0·22-3·16; p=0·025), depressive symptoms (1·52, 0·08-2·95; p=0·039), mindfulness (3·1, 0·70-5·49; p=0·022), and general health status (6·28, 2·51-10·06; p=0·002) at T1, compared with the control group. 12 week eMBCT improves fatigue, anxiety, depression, mindfulness, and health status in patients with sarcoidosis-associated fatigue. Dutch Sarcoidosis Patient Association (Sarcoidose.nl). For the Dutch translation of the summary see Supplementary Materials section.

The Effect of Listening to Quran Recitation on Score of Post-Stroke Fatigue in Acute Ischemic Stroke Patients

BACKGROUND: One of the common stroke complications is post-stroke fatigue (PSF) with the prevalence of 25–85%. PSF influences health-related quality of life, disability, dependence in daily activities, ability to return to work, and case fatality rate of stroke patients. Listening to Quran recitation can increase alpha waves in the brain, reduce stress and inflammatory biomarkers. AIM: The purpose of this study was to identify the effect of listening to Quran recitation on PSF and find out the mean Fatigue Assessment Scale (FAS) score in acute ischemic stroke patients. METHODS: This was an experimental study with one-group pretest-posttest design. Sixteen subjects were recruited by consecutive sampling in Sultan Agung Islamic Hospital, Semarang. The FAS score was assessed on the 1st day of study, then Quran recitation was played 2 sessions a day, 15 min/session, for 5 days. The FAS score was reassessed on the last day. The study was conducted from August to September 2021. The analysis test used was paired t-test. RESULTS: The results showed a significant relationship between listening to Quran recitation with changes in FAS score in acute ischemic stroke patients (p &lt; 0.05). Most of the subjects were &lt;65 years old, male, had hypertension, did not have DM, and did not smoke. CONCLUSION: Listening to Quran recitation had an effect on changes in FAS score.

Reduced Quality of Life in Patients with Non-Alcoholic Fatty Liver Disease May Be Associated with Depression and Fatigue.

Non-alcoholic fatty liver disease (NAFLD) is often thought of as clinically asymptomatic. However, many NAFLD patients complain of fatigue and low mood, which may affect their quality of life (QoL). This may create a barrier to weight loss and hinder the achievement of NAFLD therapy goals. Our study aimed to evaluate the QoL in NAFLD patients vs. healthy volunteers, and to analyze likely influencing factors. From March 2021 through December 2021, we enrolled 140 consecutive adult subjects (100 NAFLD patients and 40 controls). Overall, 95 patients with NAFLD and 37 controls were included in the final analysis. Fatty liver was diagnosed based on ultrasonographic findings. We employed 36-Item Short Form Health Survey (SF-36) to evaluate QoL, Hospital Anxiety and Depression Scale (HADS) to identify anxiety and/or depression, and Fatigue Assessment Scale (FAS) to measure fatigue. NAFLD patients had significantly lower physical component summary scores, as well as significantly higher HADS-D scores, compared with the control group (Mann-Whitney U criterion = 1140.0, p = 0.001 and U = 1294.5, p = 0.022, respectively). Likewise, fatigue was more common in NAFLD patients (χ2 = 4.008, p = 0.045). Impaired QoL was significantly associated with fatigue (FAS score ≥ 22, p < 0.001) and depression (HADS-D ≥ 8, p < 0.001). In conclusion, NAFLD patients had significantly poorer QoL vs. controls, in particular with respect to the physical component of health. Impaired QoL may be associated with fatigue and depression, and together they may interfere with increased physical activity and lifestyle modifications in patients with NAFLD.

Psychometric Properties of the Spanish Version of the Fatigue Assessment Scale in Caregivers of Palliative Care Patients.

Symptoms of fatigue and lack of energy are very common in caregivers of palliative care (PC) patients, traditionally associated with variables such as burden or depression. There are no Spanish-language instruments validated for assessing fatigue levels in this population. The Fatigue Assessment Scale (FAS) is a useful and simple instrument for assessing fatigue in this group. The aim of this study was to examine its psychometric properties (factor structure, reliability and validity) in a sample of caregivers of PC patients. Instrumental design for instrument validation was performed. One hundred and eight caregivers of PC patients participated and completed measures of fatigue, family functioning, life satisfaction, caregiver burden, anxiety, depression, resilience and quality of life. A confirmatory factor analysis was performed; non-linear reliability coefficient and Pearson correlations and t-tests were conducted to assess evidence of reliability and validity. The Spanish version of the FAS was found to have a one-dimensional structure. Reliability was 0.88. Validity evidence showed that FAS scores were positively associated with levels of burden, anxiety and depression. They were negatively associated with family functioning, life satisfaction, resilience and quality of life. The Spanish version of the FAS in caregivers of PC patients shows adequate psychometric properties.

Association of post-COVID-19 fatigue with mental health problems and sociodemographic risk factors

ABSTRACT Purpose : Our objective was to obtain an initial prevalence estimate of post-COVID-19 fatigue in Turkey and identify psychological and sociodemographic risk factors associated with post-COVID-19 fatigue. Materials and methods : The data were collected from a cross-sectional community-based survey among the population recovered from COVID-19 in Turkey. A sociodemographic data form, the Fatigue Assessment Scale (FAS), and the Depression Anxiety Stress Scale-21 (DASS-21) were included in the survey. Participants were divided into two groups, fatigued and non-fatigued, based on their FAS scores. Sociodemographic and psychological characteristics of the two groups were examined with comparative analyses, and binary regression analysis identified predictors of post-COVID-19 fatigue. Results : The completed survey (N = 275) included individuals from 50 cities in Turkey who reported a prior COVID-19 illness. The mean age was 34.67 ± 8.35 years and 58.2% were female. Significant fatigue was detected in 56.4% (155) of participants. Female gender, history of psychiatric illness, history of psychiatric drug use, and current psychiatric drug use were significantly higher in the fatigued group than in the non-fatigued group (p < 0.01). In addition, the fatigued group showed significantly higher scores on all domains of the FAS and DASS-21 scales than the non-fatigued group (p < 0.01). Female gender and a high DASS-21 total score were predictors of post-COVID-19 fatigue. Conclusion : Patients with post-COVID-19 fatigue should be evaluated for mental health issues.

Changes in fecal short-chain fatty acids following fecal microbiota transplantation in patients with irritable bowel syndrome.

BackgroundShort‐chain fatty acids (SCFAs) may play a role in the pathophysiology of irritable bowel syndrome (IBS). This study analyzed fecal SCFAs after performing fecal microbiota transplantation (FMT) in the IBS patients who were included in our previous study of the efficacy of FMT.MethodsThis study included 142 of the 164 IBS patients who participated in our previous study. They were belonging to three groups: placebo (own feces), 30‐g (superdonor feces), and 60‐g (superdonor feces) FMT. The patients completed the IBS Severity Scoring System (IBS‐SSS) Birmingham IBS Symptom, Fatigue Assessment Scale (FAS), the IBS Quality of Life (IBS‐QoL) and Short‐Form Nepean Dyspepsia Index (SF‐NDI) questionnaires and delivered fecal samples at the baseline and 1 month after FMT. The SCFA levels were determined by vacuum distillation followed by gas chromatography.Key ResultsThe fecal butyric acid level was significantly increased after FMT in both the 30‐g and 60‐g groups (both P ≤ 0.001). In the 60‐g group, the levels of total SCFAs and isobutyric, isovaleric, and valeric acids increased after FMT. Butyric acid levels in the responders in both the 30‐g and 60‐g FMT groups were significantly inversely correlated with IBS‐SSS and FAS scores (P = 0.001, r = −0.3 and P = 0.0001. r=‐ 0.3, respectively). There were no differences in the SCFA levels in the placebo group after FMT.Conclusion and InferencesFMT increases the fecal SCFA levels in IBS patients. The increase in the butyric acid level is inversely correlated with symptoms in IBS patients following FMT, suggesting that SCFAs might play a role in the pathophysiology of IBS. www.clini​caltr​ials.gov (NCT03822299).

Measuring activity in patients with sarcoidosis - a pilot trial of two wrist-worn accelerometer devices.

Introduction: Increasing physical activity is associated with health benefits. Reduced physical activity has been noted in sarcoidosis, particularly where fatigue co-exists. Monitoring physical activity is possible with wrist-worn devices. This study compared two available devices to determine patient preference and compare wear-time, with a secondary outcome of comparing device outputs with fatigue scores. Methods: Patients with sarcoidosis wore two wrist-worn activity monitors (GENEActiv actiwatch and Actigraph GT3X-bt) separately for seven days each. Participants were randomly allocated to receive either device first. Participants completed the Fatigue Assessment Scale (FAS) questionnaire immediately before wearing the first device. All participants completed a questionnaire of their perception regarding each device after the wear period. Data from the devices was analysed for total wear time, time spent in moderate or vigorous activity (MVPA) and for time spent in sedentary behaviours. Results: Twelve patients with sarcoidosis were included. The GENEActiv device was preferred by ten (83.3%) participants. Wear time was greater with the GENEActiv device (1354 minutes/day vs 1079 minutes/day). Time spent in MVPA was slightly higher when recorded by the GENEActiv compared with the Actigraph. Moderately strong correlation was seen between FAS scores and sedentary time (r=-0.554), light activity (r=-0.585) and moderate activity (r=0.506). Discussion: A clear preference was demonstrated for the GENEActiv. This was reflected in higher wear time and suggests the device can be comfortably worn 24 hours per day. Data from this small cohort also suggests there is correlation between fatigue and activity scores in patients with sarcoidosis. (Sarcoidosis Vasc Diffuse Lung Dis 2018; 35: 62-68).

Abstract TP153: Post Stroke Fatigue and Depression Predict Lower Health Related Quality of Life in Stroke Patients

Background and Purpose: Post stroke fatigue (PSF) is a common and debilitating condition that can last months or even years. Although the relationship between PSF and Health Related Quality of Life (HRQoL) has been studied, the results have been largely inconclusive and not previously reported in a minority cohort. Hypothesis: Higher levels of PSF and Post Stroke Depression (PSD), will predict lower levels of HRQoL in African/Caribbean Blacks. Methods: Prospective, cross-sectional, observational study approved by the IRB. Patients ≥ 18 years old with a stroke in the past 3 years were enrolled. Standardized questionnaires were administered to assess the patients’ levels of PSF [Fatigue Assessment Scale (FAS)], HRQoL [Short Form-36 (SF-36)], and PSD [Beck’s Depression Inventory (BDI)]. Stroke related disability was assessed by modified Rankin Scale (mRS). Responses to the SF-36 were weighted and then averaged in accordance to standard practices. FAS, BDI, and mRS scores were dichotomized and adjusted for gender. A multiple linear regression model was constructed for the HRQoL overall score. The dichotomized FAS, BDI, and mRS scores, age and gender were considered as predictors. Results: Of 100 patients enrolled (55% female), mean age = 66.7 years ± 12.8; 93% African or Caribbean American, 86% with hypertension, 53% with diabetes, and 37% with a family history of stroke/TIA. The prevalence of stroke related disability (mRS ≥ 2) was 63%, PSF (FAS≥22) was 51%, PSD (BDI ≥11) was 24%. Both PSF and PSD was seen in 20%. The cohort’s mean SF-36 score was 51.6 ± 21.1. BDI &lt;11 was associated with a score 9.5 units higher on the SF-36 (95% CI: 2.3-16.8, p =0.01) than BDI ≥ 11; mRS &lt;2 was associated with 19.8 units higher score on the SF-36 (95%CI: 13.7-25.8, p&lt;0.0001) than mRS≥2. FAS score&lt;22 was associated with 15.0 higher HRQoL score (95%CI: 8.9-21.1, p &lt;0.0001) than FAS≥ 22. The analysis was adjusted for gender ( p =0.10), while age ( p =0.29) was not included. BDI, mRS, FAS, and gender accounted for 56% of the variability in the HRQoL score. Conclusion: Our results suggest that both PSF and PSD are significantly correlated with a lower HRQoL. In this minority cohort, over half of post-stroke HRQoL is attributed to depression, disability, fatigue, and female gender.

Physical Functioning and Symptoms of Chronic Fatigue in Sarcoidosis Patients.

Scientific reports underscore the importance of measuring the health-related quality of life in sarcoidosis patients. The present study seeks to define how sarcoidosis patients' quality of life, daily physical activity, and physical performance are related to each other. Seventeen patients (mean age 46.8 ± 8.8years) suffering from sarcoidosis completed the following questionnaires: the fatigue assessment scale (FAS), the quality of life scale (SF-36 questionnaire), and the Borg dyspnea scale. Physical activity (PA) was assessed using accelerometry. Respiratory function, consisting of forced expiratory volume in one second (FEV1), forced vital capacity (FVC), forced expiratory volume in one second as a percentage of vital capacity (FEV1/%FVC), and diffusing capacity of the lungs for carbon monoxide (DLCO), were assessed. In addition, performance in 6-min walk test (MWT), aerobic capacity assessed from maximal oxygen uptake (VO2max), and the metabolic equivalent of task (MET) were evaluated. We found that daily PA (4566±2378 steps/day) and VO2max (21.8±5.9ml/kg/min) were lower in sarcoidosis patients than the known predicted values in healthy age-matched individuals. There were significant inverse associations between the FAS score and 6MWT (r=-0.62; p<0.01), and between SF-36 score and 6MWT (r=-0.55; p<0.03). In contrast, SF-36 scores associated with fatigue and dyspnea scores (r=0.72; p<0.001 and r=0.85; p<0.001). These findings imply that sarcoidosis patients are less active compared with healthy subjects. The FAS and SF-36 scales seem to be effective tools for assessing the severity of fatigue in sarcoidosis patients.

Abstract P3-09-17: One year of adjuvant hormone therapy does not increase patient fatigue: Results of a prospective early stage breast cancer trial

Abstract INTRODUCTION: The diagnosis and treatment of breast cancer may alter a patient's mental and physical quality of life. Estrogen effects on the brain may be neuroprotective or detrimental, and adjuvant endocrine therapy may influence cognitive functions including fatigue. We previously reported that three months of adjuvant hormone therapy was not associated with change in fatigue. The purpose of this study was to prospectively determine the incidence of fatigue in early stage breast cancer patients during one year of adjuvant hormone therapy. METHODS: Seventy-four consecutive patients of a single medical oncologist with newly diagnosed hormone dependent breast cancer prescribed adjuvant hormone therapy enrolled in this prospective study. Data collected included age, race, menopausal status, breast cancer stage, body mass index, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-F, Fatigue Assessment Scale (FAS), short form 36 (SF-36), and cognitive failure questionnaire (CFQ). All tests were administered by one nurse prior to hormone initiation (0 mo) and after 3, 6, 9, and 12 months (mo) of therapy. Statistical analysis was performed using Student t test for paired data with a p value of &amp;lt;0.05 considered significant. RESULTS: Prior to starting therapy, a third of patients had a FAS score of &amp;gt;22, consistent with moderate to severe fatigue. After 12 months of therapy, 52 patients (13 premenopausal, 39 postmenopausal) were still receiving adjuvant hormone therapy and had completed serial testing. Twenty patients received chemotherapy prior to institution of hormone treatment. There were no significant changes in FACIT-F, FAS, SF-36, or CFQs scores during the first 12 months of treatment. 0 mo3 mo6 mo9 mo12 moFACIT-F44 (7-52)*42 (3-52)43 (3-52)43 (2-52)44 (6-52)FAS17 (10-43)18 (10-48)17 (10-48)20 (10-48)19 (10-50)Weight, lb.159 (102-256)162 (102-258)161 (102-258)163 (102-263)164 (101-258)SF-36 Total72 (12-100)68 (15-99)83 (15-99)76 (15-99)82 (7-100)CFQ70 (39-94)69 (34-92)68 (34-94)67 (28-96)70 (20-96)* Median (Range) Although during the first six months, a small but significant increase in body weight occurred, there was no significant difference between the initial and 12 month body weight. CONCLUSION: Prior to adjuvant hormone therapy institution, breast cancer patients often have significant problems with fatigue. However, the first 12 months of adjuvant hormone therapy does not appear to affect fatigue or cognitive failure. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-09-17.

Brief Report: Attention Deficit and Hyperactivity Disorder Scores Are Elevated and Respond to N‐Acetylcysteine Treatment in Patients With Systemic Lupus Erythematosus

To investigate whether attention deficit hyperactivity disorder (ADHD) may serve as a marker of neuropsychiatric disease and as a target for N-acetylcysteine (NAC) treatment in patients with systemic lupus erythematosus (SLE). The ADHD Self-Report Scale (ASRS) was used to assess 49 patients with SLE and 46 matched healthy control subjects. Twenty-four of the patients with SLE were randomized to receive either placebo, NAC at a dosage of 2.4 gm/day, or NAC at a dosage of 4.8 gm/day. Disease activity was evaluated monthly using the British Isles Lupus Assessment Group (BILAG) index, the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), the Fatigue Assessment Scale (FAS), and the ASRS, before and during the 3-month treatment period and after a 1-month washout period. The cognitive/inattentive (ASRS part A), hyperactivity/impulsive (ASRS part B), and combined (total) ASRS scores were increased in patients with SLE compared with control subjects (mean ± SEM 17.37 ± 1.03 [P = 3 × 10(-7) ], 14.51 ± 0.89 [P = 2 × 10(-4) ], and 31.92 ± 1.74 [P = 8 × 10(-7) ], respectively, versus 10.41 ± 1.02, 9.61 ± 1.21, and 20.02 ± 1.98, respectively. ASRS part A scores correlated with SLEDAI (r = 0.53, P < 0.0001) and BILAG scores (r = 0.36, P = 0.011). ASRS total scores also correlated with SLEDAI (r = 0.45, P = 0.0009) and BILAG scores (r = 0.31, P = 0.025). ASRS part A (r = 0.73, P < 0.0001), ASRS part B (r = 0.47, P = 0.0006), and ASRS total scores (r = 0.67, P < 0.0001) correlated with the FAS score. Relative to the scores in placebo-treated patients, ASRS total scores were reduced in SLE patients treated with NAC dosages of 2.4 gm/day and 4.8 gm/day combined (P = 0.037). ASRS part A scores were reduced by NAC dosages of 2.4 gm/day (P = 0.001) and 4.8 gm/day (P < 0.0001) as well as by NAC at dosages of 2.4 gm/day and 4.8 gm/day combined (P = 0.001). In patients with SLE, elevated ASRS scores reveal previously unrecognized and clinically significant symptoms of ADHD that respond to NAC treatment.

Abstract P6-08-08: Three months of adjuvant hormone therapy does not increase fatigue or cognitive failure: results of a prospective early stage breast cancer trial.

Abstract INTRODUCTION: The diagnosis and treatment of breast cancer may alter a patient's mental and physical quality of life. Fatigue and impaired cognition have been reported after chemotherapy and hormone therapy. The purpose of this study was to prospectively determine the incidence of fatigue and cognitive changes in early stage breast cancer patients during adjuvant hormone therapy and to evaluate the relationship of dysfunction with other risk factors. METHODS: Fifty-four consecutive patients of a single medical oncologist with newly diagnosed hormone dependent breast cancer prescribed adjuvant hormone therapy enrolled in this prospective study. Data collected included age, race, menopausal status, breast cancer stage, body mass index, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-F, Fatigue Assessment Scale (FAS), short form 36 (SF-36), cognitive failure questionnaire (CFQ), Beck depression inventory (BDI-2), Epworth sleepiness scale, and facial recognition (FR) and sheep dash time (SDT) to assess executive functioning. All tests were administered by one nurse prior to hormone initiation (0 mo) and after 3 months (3 mo) of therapy. Statistical analysis was performed using Student t test for paired data with a p value of &amp;lt;0.05 considered significant. RESULTS: After 3 months of therapy, 52 of 54 patients were reevaluated (1 patient dropped out and 1 excluded for metastatic disease). Of the remaining 52 patients, the mean age was 54 years (range 30–76) with self-reported race of white 38, black 13 and Indian 1 patient and 39 (75%) patients were postmenopausal. Initial tumor stage was 0 in 8 patients, 1 in 23, 2 in 20, and 3 in 1. Although the baseline mental health of patients assessed by SF-36 mental health (MH) domain was low (70 ±22.0 [mean ±SD]) after 3 months it improved to 55 ±8.1, P &amp;lt; 0.0001. No change was found in the SF-36 domains of physical health or vitality. At baseline, 15 of 52 patients (36%) reported significant fatigue (FAS score ≥22). After 3 months of therapy fatigue as measured by either the FACIT-F (0 mo:30 ±11.2; 3 mo:31 ±9.5, p = 0.37) or FAS (0 mo:20 ±8.5; 3 mo: 20 ±7.6, p = 0.53) remained unchanged. No change was noted in depression as determined by the BDI-2 score (0 mo: 9 ±8.1 versus 3 mo:9 ± 9, p = NS) or Epworth sleepiness scores (0 mo:7 ±4.5 versus 3 mo:8 ±4.7, p = NS). The initial CFQ was considered positive (&amp;gt;43) in 48 (92%) of patients. There was no significant change in the CFQ, SDT, or FR (CFQ 0 mo:67±12.9, 3 mo:67±13.0, p = 0.453; SDT: 0 mo:0.56±0.292 secs, 3 mo:0.52±0.223 secs, p = 0.144). BMI rose minimally after hormone therapy (0 mos:28.8 ±6.41; 3 mo:29.1 ±6.43, p = 0.0498). CONCLUSION: Prior to adjuvant hormone therapy institution, breast cancer patients often have significant problems with fatigue, cognitive failure, and overall mental health. Overall mental health improved during the first three months of hormone therapy. However, there was no significant change in fatigue, cognitive failure, depression score, reaction time, or facial recognition. Longer follow–up will be performed to assess the possible cumulative effects of hormone therapy on fatigue or cognitive function. Supported by Ride Cincinnati Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P6-08-08.

N‐acetylcysteine reduces disease activity by blocking mammalian target of rapamycin in T cells from systemic lupus erythematosus patients: A randomized, double‐blind, placebo‐controlled trial

Systemic lupus erythematosus (SLE) patients exhibit T cell dysfunction, which can be regulated through mitochondrial transmembrane potential (Δψm) and mammalian target of rapamycin (mTOR) by glutathione (GSH). This randomized, double-blind, placebo-controlled study was undertaken to examine the safety, tolerance, and efficacy of the GSH precursor N-acetylcysteine (NAC). A total of 36 SLE patients received either daily placebo or 1.2 gm, 2.4 gm, or 4.8 gm of NAC. Disease activity was evaluated monthly by the British Isles Lupus Assessment Group (BILAG) index, the SLE Disease Activity Index (SLEDAI), and the Fatigue Assessment Scale (FAS) before, during, and after a 3-month treatment period. Mitochondrial transmembrane potential and mTOR were assessed by flow cytometry. Forty-two healthy subjects matched to patients for age, sex, and ethnicity were studied as controls. NAC up to 2.4 gm/day was tolerated by all patients, while 33% of those receiving 4.8 gm/day had reversible nausea. Placebo or NAC 1.2 gm/day did not influence disease activity. Considered together, 2.4 gm and 4.8 gm NAC reduced the SLEDAI score after 1 month (P = 0.0007), 2 months (P = 0.0009), 3 months (P = 0.0030), and 4 months (P = 0.0046); the BILAG score after 1 month (P = 0.029) and 3 months (P = 0.009); and the FAS score after 2 months (P = 0.0006) and 3 months (P = 0.005). NAC increased Δψm (P = 0.0001) in all T cells, profoundly reduced mTOR activity (P = 0.0009), enhanced apoptosis (P = 0.0004), reversed expansion of CD4-CD8- T cells (mean ± SEM 1.35 ± 0.12-fold change; P = 0.008), stimulated FoxP3 expression in CD4+CD25+ T cells (P = 0.045), and reduced anti-DNA production (P = 0.049). This pilot study suggests that NAC safely improves lupus disease activity by blocking mTOR in T lymphocytes.

Abstract 2388: Is Fatigue Associated With Symptoms Of Post Traumatic Stress Disorder In Subjects Following Stroke?

Introduction: Significant fatigue affecting quality of life is reported by up to 60% of stroke patients in the 6 months post event. We have previously reported an association between post fatigue and anxiety measured by Hospital Anxiety and Depression Score in stroke survivors. Stroke presents frequently as an unexpected potentially life threatening event with features similar to traumatic episodes such as accidents etc. Traumatic events may in turn be associated with development of the anxiety disorder Post Traumatic Stress Disorder (PTSD). We hypothesised that post-stroke fatigue may be related to a PTSD like phenomenon. Method: Independent patients (modified Rankin score &lt;3) who were cognitively intact (AMTS &gt;6) with a history of stroke attending a secondary prevention clinic were approached to participate in the study. All underwent a detailed 1-2 hour interview including assessment of fatigue using 2 tools, the Fatigue Assessment Scale (FAS) and the Fatigue Severity Score (FSS). PTSD severity was assessed using the Clinician Administered PTSD Scale (CAPS). The CAPS is a 30-item structured interview that corresponds to the DSM-IV criteria for PTSD. The CAPS is a standard criterion for the assessment and diagnosis of PTSD. Results: The study was terminated early after 18 patients completed assessments (15 male, median 70 years) due to unexpected distress experienced by some patients in completing the CAPS requiring referral to psychological support services. CAPS correlated strongly with FAS (r=0.72 (95%CI 0.39-0.89) p=0.0007). Seven subjects had a FAS score&gt;20, of these 3 had symptoms of moderate to severe PTSD. No subjects with a FAS &lt;21 had such symptoms (p=0.04, Fishers Exact test). The FSS also correlated with the CAPS but less strongly (r=0.50, p=0.03) Conclusion: Symptoms of PTSD are found in a proportion of patients following stroke. Although subject numbers are small there appears to be a strong correlation between fatigue severity and symptoms of PTSD in patients with stroke.