Abstract
Background
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 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.
Methods
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-hour 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.
Discussion
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-hour, water only fast in people receiving CAPOX chemotherapy for stage 2/3 colorectal cancer.
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 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.
Methods
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-hour 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.
Discussion
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-hour, water only fast in people receiving CAPOX chemotherapy for stage 2/3 colorectal cancer.
| Original language | English |
|---|---|
| Article number | 134 (2019) |
| Number of pages | 7 |
| Journal | Pilot and Feasibility Studies |
| Volume | 5 |
| DOIs | |
| Publication status | Published - 20 Nov 2019 |
Keywords
- short-term fast
- dietary restriction
- colorectal cancer
- feasibility
- RCT
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This is the final published version of the article (version of record). It first appeared online via BMC at https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-019-0505-7 . Please refer to any applicable terms of use of the publisher.
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