Development and Analysis of Weight Loss Programs for Renal Cell Carcinoma Patients on Active Surveillance
Roswell Park Cancer Institute
Summary
This clinical trial compares two different weight-loss programs, daily continuous calorie energy reduction (CER) versus (vs.) 5:2 intermittent fasting (IF), in preventing progression of kidney (renal) cancer among patients with one or more small renal masses (SRM) undergoing active surveillance (AS). Kidney cancer patients tend to have changes in metabolism that may increase body weight, but weight-loss strategies that work for best for these patients are unknown. The CER program requires a set daily limit for calories. The IF program requires fasting for 2 days a week and normal eating for the remaining 5 days. Both will include self-monitoring with interventionist feedback. This trial may help researchers determine whether the IF program works better than the CER program in improving weight loss, physical health, and/or reducing the risk of kidney cancer progression among patients with small renal masses undergoing AS
Description
PRIMARY OBJECTIVES: I. Adapt two evidence-based behavioral weight loss intervention programs (IF and CER) with a goal to cause weight loss in SRM patients on AS. II. Determine the feasibility of the two intervention programs (IF and CER). SECONDARY OBJECTIVE: I. Measure and explore preliminary effect sizes of IF vs. CER on body weight, diet, body composition, tumor growth, and rates of clinical progression and invasive treatment conversion
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * English speaking * SRM patient with biopsy-confirmed RCC who are initiating or already on AS for less than 5 years * Age 18 years or older * Body mass index (BMI) ≥ 25 kg/m\^2 * No medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component * No current medication that might affect weight loss * Not pregnant or lactating * No more than 5% body weight loss in the past 3 months * No bariatric surgery in the last 10 years Exclusion Criteria: * Non-English speaking * Less than 18 years old * BMI \< 25 k…
Interventions
- OtherIntermittent Fasting
The IF intervention will instruct participants how to fast safely, how to conduct a 5:2 fast, and encourage moderate physical activity. Self-monitoring with interventionist feedback will also be included
- OtherContinuous Energy Restriction (CER)
Lessons about lowering caloric intake each day and moderate physical activity with self-monitoring and interventionist feedback
Location
- Roswell Park Comprehensive Cancer CenterBuffalo, New York