NCT05764330

Weight Loss Interventions to Reduce Cancer Progression in Prostate Cancer Patients Under Active Surveillance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial examines weight loss interventions in reducing cancer progression in prostate cancer patients under active surveillance. Intensive lifestyle interventions that recommend modest reductions in daily caloric intake (i.e. continuous calorie energy reduction \[CER\]) are the gold-standard for weight loss, and have been tested in cancer survivors, including prostate cancer patients. However, few interventions have been developed for low-risk prostate cancer patients on active surveillance. Intermittent fasting (IF) may be superior to CER in the context of prostate cancer progression given its dual role in weight loss and metabolic switching from the use of glucose as a fuel source to the use of fatty acids and ketone bodies. This study may help researchers determine which weight loss strategies can reduce their risk of prostate cancer recurrence, and other negative health effects of being overweight or obese.

Detailed description

PRIMARY OBJECTIVES: I. Develop two evidence-based behavioral weight loss intervention programs (IF and CER) with a goal to cause weight loss in prostate cancer (PCa) patients on active surveillance (AS). II. Determine the initial comparative effectiveness of two intervention programs (IF and CER) on weight loss and PCa progression outcomes. SECONDARY OBJECTIVE: I. Compare the effects of the interventions on biomarkers underlying obesity and PCa to provide mechanistic insights and potential surrogate biomarkers for PCa prognosis. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo the CER intervention consisting of remote lessons containing information and behavioral strategies about weight loss, session with study interventionist to review lessons, and self-monitoring of body weight, physical activity and dietary intake. Patients also undergo collection of blood samples throughout the trial. ARM II: Patients undergo IF intervention consisting of remote lesson containing information and behavioral strategies about fasting, session with study interventionist to review lessons, and self-monitoring of fasting. Patients will undergo fasting 2 days per week and eat according to the National Cancer Institute (NCI) guidelines the remaining 5 days. Patients also undergo collection of blood samples throughout the trial.

Conditions

• Prostate Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
OTHER	Dietary Intervention	Undergo CER intervention
OTHER	Dietary Intervention	Undergo IF intervention
BEHAVIORAL	Fasting	Undergo fasting

Timeline

• Start date: 2024-04-24
• Primary completion: 2025-06-06
• Completion: 2025-06-30
• First posted: 2023-03-10
• Last updated: 2025-08-06

Locations

1 site across 1 country: United States