Clinical trial NCT05764330: Weight Loss Interventions to Reduce Cancer Progression in Prostate Cancer Patients Under Active Surveillance
Official title: Weight Loss Interventions to Reduce Cancer Progression in Prostate Cancer Patients Under Active Surveillance
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Carcinoma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age 18 years old or older (no upper limit)
* Body mass index (BMI) \>= 25 kg/m\^2
* English speaking
* Not currently on weight loss medications
* Prostate cancer patients who are under active surveillance (including observation) and actively followed at Roswell Park
* Not under active treatment for other cancer diagnosis
* Free of medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component
* Has not lost at least 10% of their body weight in the last 6 months
* Has not had bariatric surgery in the last 10 years
* Able to walk unassisted and continuously for 10 minutes
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* Unable to consent
* Unwilling or unable to follow protocol requirements
* Unable to complete study measures in English
* Adults who have had a myocardial infarction (heart attack) or stroke without medical clearance from their primary care physician to participate in the study
* Adults who currently have type 1 or type 2 diabetes without medical clearance from their primary care physician to participate in the study
* History of partial or radical prostatectomy

Primary outcomes:
measure: Change in Body weight
timeFrame: Up to 6 months
measure: Changes in prostate cancer (PCa) progression
timeFrame: Up to 6 months
Secondary outcomes:
measure: Dietary intake
timeFrame: Up to 6 months
measure: Physical activity
timeFrame: Up to 6 months
measure: Change from baseline in Prostate Cancer related biomarkers
timeFrame: Up to 6 months
measure: Change in Urinary functions
timeFrame: Up to 6 months
measure: Improvement of Quality of life
timeFrame: Up to 6 months
measure: Change in Sexual functions
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Karen Yeary
role: PRINCIPAL_INVESTIGATOR
References: