Renal Cell Carcinoma (RCC)NCT07714018
Comparing Two Weight Loss Programs for the Prevention of Kidney Cancer Progression Among Patients With Small Renal Masses on Active Surveillance
A study testing Intermittent Fasting and Continuous Energy Restriction (CER) in people with Renal Cell Carcinoma (RCC), run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma (RCC)
- What is being tested?
- Intermittent Fasting and Continuous Energy Restriction (CER)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Not pregnant or lactating
- No more than 5% body weight loss in the past 3 months
- No bariatric surgery in the last 10 years
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
ASK RPCI, 800-767-9355, askrpci@roswellpark.org
Eric Kauffmann, MD
About this study
Official title: Development and Analysis of Weight Loss Programs for Renal Cell Carcinoma Patients 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
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- Measure, compare 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
- Conditions
- Renal Cell Carcinoma (RCC)
- Being tested
- Intermittent Fasting, Continuous Energy Restriction (CER)
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent FastingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Arm I - CER Program | Active comparator | Patients complete the CER program for 6 months. The CER intervention will be adapted to renal cell carcinoma patients on active surveillance Receives: Other: Continuous Energy Restriction (CER) |
| Arm II - IF Program | Active comparator | 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. Receives: Other: Intermittent Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 6 months
Secondary outcomes (4)
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.
Measured: At baseline and at 6 months
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
Measured: Up to 6 months
Change in Dietary Intake
Participants will complete 3 recalls over the phone regarding dietary intake over a prior 24-hour period.
Measured: Baseline and 6 months
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..
Measured: Baseline and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma (RCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Kaufmann, Principal investigator, Roswell Park Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714018
- Sponsor's protocol ID
- I-4928826
- Status last verified
- Oct 2026
- First submitted
- 15 Jul 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Analysis of Weight Loss Programs for Renal Cell Carcinoma Patients on Active Surveillance
- ClinicalTrials.gov ID
- NCT07714018
- Acronym / sponsor ID
- I-4928826
- Conditions
- Renal Cell Carcinoma (RCC)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- Measure, compare 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I - CER Program | Active comparator | Other: Continuous Energy Restriction (CER)Patients complete the CER program for 6 months. The CER intervention will be adapted to renal cell carcinoma patients on active surveillance |
| Arm II - IF Program | Active comparator | Other: Intermittent FastingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent FastingThe 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 | Arm II - IF Program |
| Continuous Energy Restriction (CER)Lessons about lowering caloric intake each day and moderate physical activity with self-monitoring and interventionist feedback | Other | Arm I - CER Program |
Primary outcome
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
4 secondary outcomes
Change in tumor size
Time frame: At baseline and at 6 months
Rate of clinical progression
Time frame: Up to 6 months
Change in Dietary Intake
Time frame: Baseline and 6 months
Change in Body composition
Time frame: Baseline and at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Kaufmann principal investigator
Roswell Park Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Fasting and Continuous Energy Restriction (CER) in people with Renal Cell Carcinoma (RCC), run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ASK RPCI (1-800-767-9355, askroswell@roswellpark.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation Rate (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.