About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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/m²
Disqualifiers
Non-English speaking
Less than 18 years old
BMI < 25 kg/m²
Medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component
Trial design
Parallel
Treatments tested in this trial
Intermittent Fasting
Other interventionThe 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 interventionLessons about lowering caloric intake each day and moderate physical activity with self-monitoring and interventionist feedback
Treatment groups
Trial 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
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.
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
Change in Dietary Intake
Participants will complete 3 recalls over the phone regarding dietary intake over a prior 24-hour period.
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..
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