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NCT07714018

Overview

NCT ID: NCT07714018
Lead Sponsor: Roswell Park Cancer InstituteOTHER
Official Title: Development and Analysis of Weight Loss Programs for Renal Cell Carcinoma Patients on Active Surveillance
Brief 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
Conditions

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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 kg/m^2

Medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component

Current medication that might affect weight loss

Pregnant or lactating

More than 105% body weight loss in the past 6 months

Bariatric surgery in the last 10 years

Medical conditions that might contraindicate short-term fasting periods

Unwilling or unable to follow protocol requirements

Received an investigational agent within 30 days prior to enrollment