Amber S Kleckner, Brian J Altman, Jennifer E Reschke, Ian R Kleckner, Eva Culakova, Richard F Dunne, Karen M Mustian, Luke J Peppone
{"title":"限制进食时间以解决癌症幸存者与癌症相关的疲劳：单臂试点研究","authors":"Amber S Kleckner, Brian J Altman, Jennifer E Reschke, Ian R Kleckner, Eva Culakova, Richard F Dunne, Karen M Mustian, Luke J Peppone","doi":"","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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, <i>p</i>=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 (<i>p</i><0.001, effect size [ES]=0.55), 30.6 ± 35.9 points for the FACIT-F total score (<i>p</i><0.001, ES=0.50), and -1.0 ± 1.7 points on the BFI (<i>p</i><0.001, ES=-0.58).</p><p><strong>Conclusion: </strong>A 10-h TRE intervention was feasible and safe among survivors, and fatigue improved with a moderate effect size after two weeks.</p><p><strong>Limitations: </strong>This was a single-arm study, so it is possible that expectation effects were present for fatigue outcomes, independent of effects of TRE <i>per se</i>. However, this feasibility trial supports evaluation of TRE in randomized controlled trials to address persistent cancer-related fatigue.</p>","PeriodicalId":16252,"journal":{"name":"Journal of Integrative Oncology","volume":"11 5","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9489052/pdf/","citationCount":"0","resultStr":"{\"title\":\"Time-restricted Eating to Address Cancer-related Fatigue among Cancer Survivors: A Single-arm Pilot Study.\",\"authors\":\"Amber S Kleckner, Brian J Altman, Jennifer E Reschke, Ian R Kleckner, Eva Culakova, Richard F Dunne, Karen M Mustian, Luke J Peppone\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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, <i>p</i>=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 (<i>p</i><0.001, effect size [ES]=0.55), 30.6 ± 35.9 points for the FACIT-F total score (<i>p</i><0.001, ES=0.50), and -1.0 ± 1.7 points on the BFI (<i>p</i><0.001, ES=-0.58).</p><p><strong>Conclusion: </strong>A 10-h TRE intervention was feasible and safe among survivors, and fatigue improved with a moderate effect size after two weeks.</p><p><strong>Limitations: </strong>This was a single-arm study, so it is possible that expectation effects were present for fatigue outcomes, independent of effects of TRE <i>per se</i>. 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引用次数: 0
摘要
目的：与癌症相关的疲劳是一种普遍存在的使人衰弱的症状，在治疗后可能会持续数月或数年。在一项单臂临床试验中，对癌症幸存者进行了限时进食（TRE）干预的可行性和安全性评估，并初步估算了癌症相关疲劳在人体内的变化情况：参与者为癌症治疗后 4-60 个月的患者，有疲劳感（0-10 分≥ 3 分），且未进行限时进食干预。TRE要求在14天内限制所有食物和饮料的摄入量，限制时间为自选的10小时。参与者在每日日记中报告自己的进食时间，并在干预前和干预后完成慢性疾病治疗-疲劳功能评估（FACIT-F）、简易疲劳量表（BFI）和症状量表。这项研究已于2020年1月在clinicaltrials.gov网站进行了预注册（NCT04243512）：参与者（39 人）的年龄为 61.5 ± 12.4 岁，治疗后 1.8 ± 1.3 年；89.7% 曾患乳腺癌。干预是可行的，36/39（92.3%）的参与者完成了所有问卷和每日日记。干预也很安全，没有出现严重的不良反应或体重快速下降（平均下降 1.1 ± 2.3 磅，P=0.008）。大多数人都坚持了TRE；86.1%的人至少有80%的时间在10小时内进食，平均进食时间为（9.33±1.05）小时。在FACIT-F疲劳分量表中，疲劳得分提高了（5.3±8.1）分（ppp结论：10小时TRE干预是可行的：10 小时 TRE 干预在幸存者中是可行和安全的，两周后疲劳状况得到改善，效果中等：局限性：这是一项单臂研究，因此疲劳结果可能存在期望效应，而与 TRE 本身的效果无关。不过，这项可行性试验支持在随机对照试验中对 TRE 进行评估，以解决癌症相关的持续疲劳问题。
Time-restricted Eating to Address Cancer-related Fatigue among Cancer Survivors: A Single-arm Pilot Study.
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.
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