Clinical trial · Interventional
Comparing Two Weight Loss Programs for the Prevention of Kidney Cancer Progression Among Patients With Small Renal Masses on Active Surveillance
Development and Analysis of Weight Loss Programs for Renal Cell Carcinoma Patients on Active Surveillance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma (RCC) | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Continuous Energy Restriction (CER) | Other | — | UNRESOLVED |
| Intermittent Fasting | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I - CER Program
- description
- Patients complete the CER program for 6 months. The CER intervention will be adapted to renal cell carcinoma patients on active surveillance
- interventionNames
- Other: Continuous Energy Restriction (CER)
- type
- ACTIVE_COMPARATOR
- label
- Arm II - IF Program
- description
- 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.
- interventionNames
- Other: Intermittent Fasting
Primary outcomes (1)
- measure
- Participation Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available