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NCT Number: NCT07714018

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location contact

Eric Kauffmann, MD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intermittent fasting

Other

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

Primary outcomes

  1. Participation Rate

    Time frame: 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 outcomes

  1. Change in tumor size

    Time frame: 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.

  2. Rate of clinical progression

    Time frame: 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

  3. Recall of Dietary Intake

    Time frame: Baseline and 6 months

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

  4. Change in Body composition

    Time frame: 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..

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

Development and Analysis of Weight Loss Programs for Renal Cell Carcinoma Patients on Active Surveillance

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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