Renal Cell Carcinoma (RCC)
Conditions
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
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 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
Interventions
OTHERIntermittent 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
Lessons about lowering caloric intake each day and moderate physical activity with self-monitoring and interventionist feedback
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participation Rate | At 6 months | This will assess the rate of eligible persons who enroll after invitation and the mean proportion of intervention components completed by arm and participant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in tumor size | At baseline and at 6 months | 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. |
| Rate of clinical progression | Up to 6 months | 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 |
| Recall of Dietary Intake | Baseline and 6 months | Participants will complete 3 recalls over the phone regarding dietary intake over a prior 24-hour period. |
| Change in Body composition | Baseline and at 6 months | Will be measured using a body composition monitor, which uses bioelectrical impedance analysis to measure whole body and segmental body composition, including trunk fat.. |
Countries
United States
Outcome results
None listed