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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoswell Park Cancer Institute

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Intermittent Fasting

    Other intervention

    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 intervention

    Lessons about lowering caloric intake each day and moderate physical activity with self-monitoring and interventionist feedback

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Arm I - CER ProgramActive comparator 1 intervention
Group B: Arm II - IF ProgramActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
At 6 months

Secondary outcomes

1

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.

Time frame
At baseline and at 6 months
2

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

Time frame
Up to 6 months
3

Change in Dietary Intake

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

Time frame
Baseline and 6 months
4

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..

Time frame
Baseline and at 6 months

Other outcomes

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