Shingler Ellie, Perks Claire, Herbert Georgia, Ness Andy, Atkinson Charlotte
NIHR Bristol Biomedical Research Centre (Nutrition Theme), Level 3, University Hospitals Bristol Education Centre, Upper Maudlin Street, Bristol, BS2 8AE England.
2School of Clinical Sciences, University of Bristol, Bristol, England.
Pilot Feasibility Stud. 2019 Nov 20;5:134. doi: 10.1186/s40814-019-0505-7. eCollection 2019.
Capecitabine and oxaliplatin (CAPOX) chemotherapy is a standard treatment for stage 2/3 colorectal cancer. Treatment is associated with dose-limiting toxicities such as neutropenia, vomiting, diarrhoea, and stomatitis. Short-term fasting prior to chemotherapy may help protect normal cells from the toxic effects of chemotherapy by allowing them to conserve energy for maintenance and repair. However, there is a lack of evidence to support the efficacy of short-term fasting in protecting against chemotherapy-related toxicities in humans, and it is not known whether people due to undergo chemotherapy will be willing and able to follow a short-term fast. Preliminary data confirming this is feasible are required before adequately powered trials can be designed and conducted.
The short-term, water only, fasting trial (SWiFT) is a two-armed feasibility randomised controlled trial, aiming to recruit 30 people scheduled to begin routine treatment with CAPOX chemotherapy for stage 2/3 colorectal cancer. Participants will be randomly allocated, in a 1:1 ratio, to either a 36-h fast or standard dietary advice prior to chemotherapy administration for the first 3 cycles of chemotherapy. The primary outcome measures will assess the feasibility of the trial and include: adherence to intervention, recruitment, retention, and data completion rates as well as the acceptability of the intervention which will be qualitatively assessed. The secondary outcome measures aim to provide further information on possible outcomes of interest for a definitive trial and include side effects of chemotherapy, quality of life, markers of cellular metabolism and inflammation, appetite, and sarcopenia.
It is not known whether it is possible to recruit to a trial of short-term fasting in this population, or whether participants would be able to adhere to the intervention. Therefore, we aim to test the feasibility of a pre-chemotherapy, 36-h, water-only fast in people receiving CAPOX chemotherapy for stage 2/3 colorectal cancer.
This trial has been registered with the ISRCTN Registry. Trial registration no: ISRCTN17994717. Date of registration: 23 October 2018. URL: http://www.isrctn.com/ISRCTN17994717.
卡培他滨和奥沙利铂（CAPOX）化疗是2/3期结直肠癌的标准治疗方法。该治疗与剂量限制性毒性相关，如中性粒细胞减少、呕吐、腹泻和口腔炎。化疗前短期禁食可能有助于保护正常细胞免受化疗的毒性作用，使它们能够保存能量用于维持和修复。然而，缺乏证据支持短期禁食对预防人类化疗相关毒性的疗效，而且尚不清楚即将接受化疗的患者是否愿意并能够进行短期禁食。在设计和开展有足够效力的试验之前，需要初步数据证实这是可行的。
短期仅饮水禁食试验（SWiFT）是一项双臂可行性随机对照试验，旨在招募30名计划开始接受CAPOX化疗治疗2/3期结直肠癌的患者。在化疗的前3个周期给药前，参与者将按1:1的比例随机分配至36小时禁食组或标准饮食建议组。主要结局指标将评估试验的可行性，包括：干预的依从性、招募、保留和数据完成率，以及将进行定性评估的干预的可接受性。次要结局指标旨在为确定性试验提供有关可能感兴趣的结局的更多信息，包括化疗的副作用、生活质量、细胞代谢和炎症标志物、食欲和肌肉减少症。
尚不清楚在该人群中招募短期禁食试验的参与者是否可行，或者参与者是否能够坚持干预措施。因此，我们旨在测试在接受CAPOX化疗治疗2/3期结直肠癌的患者中，化疗前进行36小时仅饮水禁食的可行性。
本试验已在ISRCTN注册中心注册。试验注册号：ISRCTN17994717。注册日期：2018年10月23日。网址：http://www.isrctn.com/ISRCTN17994717
