Assessing Successful Completion of Calorie Restriction Studies for the Prevention and Treatment of Cancer
Colin E.Champ Nutrition Available online 19 April 2020,
Highlights
• In total, 29 registered studies have addressed the role of calorie restriction in cancer treatment and prevention.
• Of these 29 registered studies, only four actually reported on results.
• Target caloric restriction in the studies ranged from 500-1,000 kcal/d with one study aim of 20% CR; no study reported rates of actual caloric intake.
• Only one of the four reported studies commented on the side effects of the calorie restriction regimen.
• Those studies that reported on results revealed favorable changes in regard to associations with cancer outcomes.
• Reasons for the lack of completion and publication are unknown, however, future study design should consider these findings.
Background
Calorie restriction (CR) over 20% has been hypothesized to aid cancer prevention and treatment. Yet, there is a lack of reported studies in humans describing tolerance, adherence, or efficacy, and unpublished and incomplete dietary studies may indicate lack of tolerability and compliance.
Objective
Due to the lack of published studies, we thoroughly assessed registered clinical trials utilizing CR for cancer treatment and prevention, rates of completion, and published reports.
Research Methods & Procedures
Current registered clinical trials assessing CR in cancer prevention and treatment were assessed at clinicaltrials.gov and the International Clinical Trials Registry at the World Health Organization. Assessment of study completion and publication was calculated and compared with methods of CR utilized, as were rates of inactive and incomplete studies, dormant studies, time of dormancy, type of study, and generalizable conclusions.
Results
In total, 29 trials were registered assessing CR in cancer treatment or prevention, 18 met initial criteria, and only four studies had completed and published results. Three of these tested a CR regimen incorporating exercise or intermittent restriction. Target CR ranged from 500-1,000 kcal/d with one study aim of 20% CR; no study reported rates of actual caloric intake. The majority of dormant and unpublished studies (69%) utilized general dietary CR and was without update ranging from 265-2518 days. Only one study reported on the side effects of the CR regimen; compliance and adherence to the regimen was described in the four completed studies that reported results. Only two studies were registered as pilot studies testing the feasibility of CR.
Conclusions
Poor completion and lack of reporting of results is apparent in the majority of studies assessing calorie restriction for cancer prevention or treatment. These findings should be considered during the design of future studies assessing dietary strategies for cancer prevention or treatment.