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

Roswell Park Cancer Institute20 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Renal Cell Carcinoma (RCC)

Interventions

Intermittent FastingOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: At 6 months

Secondary Outcomes

Change in tumor size

Will be assessed based on radiologic imaging. Within-group differences between baseline and 6 months will be examined using paired t-tests or Wilcoxon signed-rank tests for continuous variables, and McNemar's test for categorical variables.

Time frame: At baseline and at 6 months

Rate of clinical progression

defined based on radiologic tumor size (\> 4 cm), stage (\> cT1a) and growth rate (\> 5 mm/year for \< 3 cm size; \> 3 mm/year for tumor size \> 3 cm), in addition to biopsy histology (high grade or unclassified renal cell carcinoma histologic subtype) and patient symptomology (bleeding or paraneoplastic symptoms/signs attributable to the tumor), as per the International Consultation for Urologic Disease guidelines

Time frame: Up to 6 months

Change in Dietary Intake

Participants will complete 3 recalls over the phone regarding dietary intake over a prior 24-hour period.

Time frame: Baseline and 6 months

Change in Body composition

Will be measured using a body composition monitor, which uses bioelectrical impedance analysis to measure whole body and segmental body composition, including trunk fat..

Time frame: Baseline and at 6 months