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

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT07714018
Status
Not Yet Recruiting

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Conditions

  • Renal Cell Carcinoma (RCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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

Key Dates

First listed
Jul 20, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Sep 1, 2027
Completion
Sep 1, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Arm I - CER Program
    Patients complete the CER program for 6 months. The CER intervention will be adapted to renal cell carcinoma patients on active surveillance
  • Active Comparator: Arm II - IF Program
    Patients will complete the IF program for 6 months. The IF arm will mirror the CER arm with the exception that IF additionally include 2 fasting days per week during which participants will be instructed to eat one 500-600kcal meal per fasting day.

Primary Outcome Measure

Participation Rate [ Time Frame: At 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263
Eric Kauffmann, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Roswell Park Comprehensive Cancer Center· Buffalo, NY

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