NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07714018

RecruitingNA

Sponsor: Roswell Park Cancer Institute

Conditions: Renal Cell Carcinoma (RCC)

Interventions: Intermittent Fasting, Continuous Energy Restriction (CER)

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Buffalo, New York, United States