Overview
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, compare 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
Inclusion Criteria:
- English speaking
- SRM patient with biopsy-confirmed RCC who are initiating or already on AS
- 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 weight loss medication in the past 3 months
- 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 kg/m\^2
- Medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component
- On weight loss medication in the past 3 months
- Pregnant or lactating
- More than 5% body weight loss in the past 3 months
- Bariatric surgery in the last 10 years
- Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug
- Unwilling or unable to follow protocol requirements
- Received an investigational agent within 30 days prior to enrollment
