Comparing Two Weight Loss Programs for the Prevention of Kidney Cancer Progression Among Patients With Small Renal Masses on Active Surveillance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intermittent Fasting, Continuous Energy Restriction (CER).
- Who it may be relevant to
- Registry conditions: Renal Cell Carcinoma (RCC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Analysis of Weight Loss Programs for Renal Cell Carcinoma Patients on Active Surveillance
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
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
- 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 - Other Continuous Energy Restriction (CER)
Lessons about lowering caloric intake each day and moderate physical activity with self-monitoring and interventionist feedback
Primary outcome measures
- Participation Rate [Time frame: At 6 months]
Secondary outcome measures (4)
- Change in tumor size [Time frame: At baseline and at 6 months]
- Rate of clinical progression [Time frame: Up to 6 months]
- Recall of Dietary Intake [Time frame: Baseline and 6 months]
- Change in Body composition [Time frame: Baseline and at 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Roswell Park Comprehensive Cancer Center — Buffalo
Identifiers
NCT: NCT07714018 · I-4928826