Recruiting

CER vs. IF

Sponsor:

Roswell Park Cancer Institute

Code:

NCT07714018

Conditions

Renal Cell Carcinoma (RCC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intermittent Fasting

Continuous Energy Restriction (CER)

Study Details

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)

Study ID

NCT07714018

Start date

Sep 1, 2026

Status verified date

Aug, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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

Continuous Energy Restriction (CER)

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

Primary outcome measure

  • Participation Rate [ Time Frame: At 6 months ]

Central Contacts and Locations

Central contacts

ASK RPCI

1-800-767-9355askroswell@roswellpark.org

Locations

Roswell Park Comprehensive Cancer Center

Recruiting

Buffalo, New York, United States, 14263

Contacts

ASK RPCI

800-767-9355askrpci@roswellpark.org

Principal Investigator:

Eric Kauffmann, MD

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2026-08-20.