Dataset Information

Time-restricted Eating to Address Cancer-related Fatigue among Cancer Survivors: A Single-arm Pilot Study.

ABSTRACT:

Purpose

Cancer-related fatigue is a prevalent, debilitating condition that can persist for months or years after treatment. In a single-arm clinical trial, the feasibility and safety of a time-restricted eating (TRE) intervention were evaluated among cancer survivors, and initial estimates of within-person change in cancer-related fatigue were obtained.

Methods

Participants were 4-60 months post-cancer treatment, were experiencing fatigue (≥ 3 on a scale 0-10), and were not following TRE. TRE entailed limiting all food and beverages to a self-selected 10-h window for 14 days. Participants reported their eating window in a daily diary and completed the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Brief Fatigue Inventory (BFI), and symptom inventory pre- and post-intervention. This study was pre-registered at clinicaltrials.gov in January 2020 (NCT04243512).

Results

Participants (n=39) were 61.5 ± 12.4 years old and 1.8 ± 1.3 years post-treatment; 89.7% had had breast cancer. The intervention was feasible in that 36/39 (92.3%) of participants completed all questionnaires and daily diaries. It was also safe with no severe adverse events or rapid weight loss (average loss of 1.1 ± 2.3 pounds, p=0.008). Most adhered to TRE; 86.1% ate within a 10-h window at least 80% of the days, and the average eating window was 9.33 ± 1.05 h. Fatigue scores improved 5.3 ± 8.1 points on the FACIT-F fatigue subscale (p<0.001, effect size [ES]=0.55), 30.6 ± 35.9 points for the FACIT-F total score (p<0.001, ES=0.50), and -1.0 ± 1.7 points on the BFI (p<0.001, ES=-0.58).

Conclusion

A 10-h TRE intervention was feasible and safe among survivors, and fatigue improved with a moderate effect size after two weeks.

Limitations

This was a single-arm study, so it is possible that expectation effects were present for fatigue outcomes, independent of effects of TRE per se. However, this feasibility trial supports evaluation of TRE in randomized controlled trials to address persistent cancer-related fatigue.

SUBMITTER: Kleckner AS

PROVIDER: S-EPMC9489052 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

Time-restricted Eating to Address Cancer-related Fatigue among Cancer Survivors: A Single-arm Pilot Study.

Kleckner Amber S AS Altman Brian J BJ Reschke Jennifer E JE Kleckner Ian R IR Culakova Eva E Dunne Richard F RF Mustian Karen M KM Peppone Luke J LJ

Journal of integrative oncology 20220530 5

<h4>Purpose</h4>Cancer-related fatigue is a prevalent, debilitating condition that can persist for months or years after treatment. In a single-arm clinical trial, the feasibility and safety of a time-restricted eating (TRE) intervention were evaluated among cancer survivors, and initial estimates of within-person change in cancer-related fatigue were obtained.<h4>Methods</h4>Participants were 4-60 months post-cancer treatment, were experiencing fatigue (≥ 3 on a scale 0-10), and were not follow ...[more]

PMID: 36131848

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Project description:Age-related cerebromicrovascular endothelial dysfunction underlies the initiation and progression of cognitive dysfunction and dementia, thus increasing the susceptibility of older adults to such conditions. Normal brain function requires dynamic adjustment of cerebral blood flow to meet the energetic demands of active neurons, which is achieved the homeostatic mechanism neurovascular coupling (NVC). In this context, therapeutical strategies aimed at rescuing or preserving NVC responses can delay the incidence or mitigate the severity of age-related cognitive dysfunction, and time-restricted eating (TRE) is a potential candidate for such a strategy. Studies have reported that TRE can improve cardiometabolic risk factors in older adults. However, the effect of TRE on cerebrovascular endothelial function remains unexplored. Thus, this protocol outlines the study procedures to test our hypothesis that a 6-month TRE regimen of 10-h eating window will improve NVC responses and endothelial function in community-dwelling older adults. This is a single-arm, open-label interventional trial. We aim to recruit 32 adults aged 55-80 years. Participants are instructed to maintain a TRE regimen of 10 h of free eating followed by 14 h of fasting for 6 months. Before and after fasting, participants are assessed for cognitive performance, peripheral micro- and macrovascular endothelial function, and NVC responses, as well as for several confounding factors, including body composition, dietary, and physical activity data. We expect that 6 months of TRE will improve NVC response and endothelial function in older adults compared with baseline, and that these improvements will be accompanied by improvements in cognitive performance. The study proposed herein will provide critical insight into a new potential therapeutical strategy for targeting age-related cognitive dysfunction. Ultimately, slowing down or alleviating cognitive decline will translate into improved quality of life and longer healthspan for aging adults. This study was prospectively registered at ClinicalTrials.gov (NCT06019195) on August 24, 2023.

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Project description:BackgroundChronic fatigue is a common symptom among patients who have been treated for cancer. Current psychosocial interventions typically target the patient alone, despite growing evidence suggesting that a couples' approach can increase and broaden the efficacy of an intervention. Therefore, based on an existing web-based mindfulness-based cognitive therapy for patients, the couple intervention COMPANION was developed.ObjectiveThe primary objectives of this study are to determine the acceptability of COMPANION and its potential efficacy in reducing fatigue in patients with cancer. Our secondary objectives are to examine the feasibility of the trial procedures and the potential working mechanisms of the couple intervention.MethodsWe will conduct a single-arm pilot trial for couples (ie, patients with cancer with chronic fatigue and their partners). All couples are allocated to the web-based couple intervention that consists of psychoeducation, mindfulness, and cognitive-behavioral exercises. The 9 sessions of the intervention are supervised remotely by a trained therapist. Patients and partners will complete questionnaires before starting the intervention (T0), 2 weeks after completing the intervention (T1), and 1 month after T1 (T2). They will also fill out weekly diaries during the intervention period. A subsample of patients (n≈5) and partners (n≈5) as well as all the therapists providing COMPANION will participate in the final focus groups. Benchmark values have been defined to determine the acceptability (ie, ≥60% of couples complete the intervention and/or ≥70% of the participants are satisfied with the intervention) and potential efficacy (ie, a significant improvement in fatigue and/or a clinically relevant improvement in fatigue in 45% of the patients between T0 and T1) of the intervention. The trial procedures are deemed feasible if an average of at least three couples are included per recruiting month and/or adherence to the assessments is at least 65% for T1 and the diaries and 60% for T2. To establish potential working mechanisms, changes in affect, sleep, catastrophizing, partner communication and interactions, self-efficacy, mindfulness, and closeness will be examined. Quantitative outcomes will be interpreted along with the results from the focus groups.ResultsData collection is expected to be completed by March 2024.ConclusionsThis pilot trial will test the first web-based mindfulness-based cognitive therapy for couples targeting chronic cancer-related fatigue. Findings will indicate whether proceeding with a randomized controlled trial is warranted.Trial registrationClinicalTrials.gov NCT05636696; https://clinicaltrials.gov/study/NCT05636696.International registered report identifier (irrid)DERR1-10.2196/48329.

Dataset Information

Time-restricted Eating to Address Cancer-related Fatigue among Cancer Survivors: A Single-arm Pilot Study.

Purpose

Methods

Results

Conclusion

Limitations

Publications

Time-restricted Eating to Address Cancer-related Fatigue among Cancer Survivors: A Single-arm Pilot Study.

Similar Datasets

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