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Comparing Two Weight Loss Programs for the Prevention of Kidney Cancer Progression Among Patients With Small Renal Masses on Active Surveillance

Sponsor: Roswell Park Cancer Institute • ClinicalTrials.gov ID: NCT07714018

Registry updated: 2026-10-16

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Description

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

Interventions

Intermittent Fasting (Other)
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
Continuous Energy Restriction (CER) (Other)
Lessons about lowering caloric intake each day and moderate physical activity with self-monitoring and interventionist feedback

Eligibility criteria

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

Conditions

Renal Cell Carcinoma (RCC)

Locations

Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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