NCT07714018 · Roswell Park Cancer Institute
Comparing Two Weight Loss Programs for the Prevention of Kidney Cancer Progression Among Patients With Small Renal Masses on Active Surveillance
What this study is about
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).
View original scientific 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.
Interventions
OTHER
Intermittent 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
OTHER
Continuous Energy Restriction (CER)
Lessons about lowering caloric intake each day and moderate physical activity with self-monitoring and interventionist feedback
Primary outcome measures
Participation Rate
Time frame: At 6 months
This will assess the rate of eligible persons who enroll after invitation and the mean proportion of intervention components completed by arm and participant
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Buffalo, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 20, 2026 · Source of record for eligibility and locations