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Weight Loss Interventions for Prostate Cancer
N/A
Recruiting
Led By Karen Yeary
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at weight loss interventions to stop prostate cancer from progressing in patients under active surveillance. It will compare the gold-standard of calorie reduction with intermittent fasting to determine which is better.
Who is the study for?
This trial is for overweight or obese prostate cancer patients under active surveillance, with a BMI of at least 25. Participants must be adults who can walk unassisted, have not had significant weight loss or bariatric surgery recently, and are not on weight loss meds. They should understand English and the study's nature.
What is being tested?
The study tests whether intermittent fasting (IF) or continuous calorie energy reduction (CER) is more effective in reducing cancer progression in prostate cancer patients. It explores IF's potential benefits over CER due to metabolic changes alongside weight loss.
What are the potential side effects?
Potential side effects may include typical reactions to dietary changes such as hunger pangs, fatigue, irritability, headaches during adjustment periods to fasting regimens, and possible nutritional deficiencies if diets are not well-balanced.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Body weight
Changes in prostate cancer (PCa) progression
Secondary study objectives
Change from baseline in Prostate Cancer related biomarkers
Change in Sexual functions
Change in Urinary functions
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (IF)Experimental Treatment3 Interventions
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 body weight. Patients also undergo fasting 2 days per week and eat according to the NCI guidelines the remaining 5 days. Patients also undergo collection of blood samples throughout the trial.
Group II: Arm I (CER)Active Control2 Interventions
Patients undergo CER intervention consisting of remote lesson containing information and behavioral strategies about weight loss, session with study interventionist to review lessons, and self-monitoring of body weight. Patients also undergo collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020
Fasting
2019
Completed Phase 4
~1090
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
412 Previous Clinical Trials
32,760 Total Patients Enrolled
19 Trials studying Prostate Cancer
1,291 Patients Enrolled for Prostate Cancer
Karen YearyPrincipal InvestigatorRoswell Park Cancer Institute
2 Previous Clinical Trials
93 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have not had weight loss surgery in the past 10 years.I am not taking any weight loss medications.I have not lost 10% or more of my weight in the past 6 months.I have had surgery to remove part or all of my prostate.I can walk by myself for 10 minutes without stopping.I am not currently being treated for another type of cancer.I am unable to give consent by myself.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (IF)
- Group 2: Arm I (CER)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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