Colorectal cancer Cancer Colorectal cancer
Conditions
Interventions
Participants will be randomly allocated, in a 1:1 ratio, to either a 36-hour fast (intervention arm) or standard dietary advice (control arm). Randomisation will be completed in a 1:1 ratio using rand
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older 2. Histologically confirmed stage 2/3 colorectal cancer which is being treated with adjuvant CAPOX chemotherapy 3. Performance status =2 4. Able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Confirmed cachexia 2. Confirmed diabetes 3. Body mass index (BMI) =18.5 kg/m² 4. History of an eating disorder 5. Recent history of drug or alcohol abuse 6. Participating in another study that may affect the outcomes of this feasibility trial 7. Unable to speak/understand English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of the trial: 1. Adherence to intervention, assessed by analysis of self-reported hour food logs, completed by participants during the 36-hour fast. Participants will be considered to have adhered to the fast if they consume less than 14% of their Basal Metabolic Rate (BMR) requirements (kcal/day calculated using the Oxford equations for BMR), in the 36 hours prior to chemotherapy administration. The percentage of adherent participants will be reported for each cycle. Reasons for non-adherence will also be recorded. 2. Recruitment rates, calculated as the percentage of eligible patients recruited each month, as recorded in the recruitment logs at each site. 3. Retention rates, calculated as the number of participants who completed data collection for each fasting cycle divided by the number of participants randomised. 4. Acceptability and tolerability of the intervention, qualitatively assessed through in depth semi-structured interviews with a subset of the trial participants when they have completed the trial 5. Data completion rates, assessed by calculating data completeness for all measures at each cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Side effects of chemotherapy, assessed on day 1 of each cycle prior to administration, and then as a follow-up on day 3 and day 7 using: 1.1. Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) 1.2. Full Blood Count (FBC) 1.3. Blood chemistry analysis Data will also be recorded on whether participants completed their first 3 cycles of chemotherapy and reasons for dose reductions/delays/early termination. 2. Quality of Life, assessed using the EQ-5D-5L health-related quality of life instrument at the baseline and days 1, 3 and 7 of each cycle 3. Haematologic toxicities, assessed using routine FBC data collected prior to each round of chemotherapy and classified according to CTCAE criteria 4. Markers of cellular metabolism - baseline samples will be collected prior to fasting and follow-up samples will be collected prior to chemotherapy administration at cycles 1 and 3. Measures will include: 4.1. Glucose (measured from blood samples) 4.2. Insulin (measured from blood samples) 4.3. IGF-I (measured from serum samples) 4.4. IGF-II (measured from serum samples) 4.5. IGFBP-2 (measured from serum samples) 4.6. IGFBP-3 (measured from serum samples) 5. Markers of inflammation (C-reactive protein (CRP)) measured from blood samples at the baseline (pre-fast) and prior to chemotherapy administration at cycles 1 and 3 6. Appetite, assessed using visual analogue scales (VAS) at the baseline and days 1, 3 and 7 of each cycle 7. Sarcopenia, assessed using the following at the baseline and at cycle 3, along with at staging and follow-up CT scans: 7.1. Computerised Tomography (CT) 7.2. Hand grip dynamometer | — |
Countries
England, United Kingdom
Contacts
Public ContactEllie Shingler
Outcome results
None listed