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

NCT07714018 | Not Yet Recruiting

• 1 other identifier: I-4928826
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Renal Cell Carcinoma (RCC)

Outcome Measures

Primary Outcomes (1)

• Participation Rate

  This will assess the rate of eligible persons who enroll after invitation and the mean proportion of intervention components completed by arm and participant

  At 6 months

Secondary Outcomes (4)

• Change in tumor size

  At baseline and at 6 months

• Rate of clinical progression

  Up to 6 months

• Recall of Dietary Intake

  Baseline and 6 months

• Change in Body composition

  Baseline and at 6 months

Study Arms (2)

Arm I - CER Program

ACTIVE COMPARATOR

Patients complete the CER program for 6 months. The CER intervention will be adapted to renal cell carcinoma patients on active surveillance

Other: Continuous Energy Restriction (CER)

Arm II - IF Program

ACTIVE COMPARATOR

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.

Other: Intermittent Fasting

Interventions

Continuous Energy Restriction (CER) OTHER

Lessons about lowering caloric intake each day and moderate physical activity with self-monitoring and interventionist feedback

Arm I - CER Program

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

Arm II - IF Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

US (1)