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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Other: Continuous Energy Restriction (CER)
    Lessons about lowering caloric intake each day and moderate physical activity with self-monitoring and interventionist feedback
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.
  • 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

Recruiting Locations

Roswell Park Comprehensive Cancer Center
Buffalo, New York 14263
Contact:
ASK RPCI
800-767-9355
askrpci@roswellpark.org

More Details

Status
Recruiting
Sponsor
Roswell Park Cancer Institute

Study Contact

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

Detailed Description

PRIMARY OBJECTIVES: I. Adapt two evidence-based behavioral weight loss intervention programs (IF and CER) with a goal to cause weight loss in SRM patients on AS. II. Determine the feasibility of the two intervention programs (IF and CER). SECONDARY OBJECTIVE: I. Measure, compare and explore preliminary effect sizes of IF vs. CER on body weight, diet, body composition, tumor growth, and rates of clinical progression and invasive treatment conversion

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.