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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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Body weight

Changes in prostate cancer (PCa) progression

Secondary outcome measures

Change from baseline in Prostate Cancer related biomarkers

Change in Sexual functions

Change in Urinary functions

+3 more

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 2

~1700

Fasting

2019

Completed Phase 4

~1090

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

30,787 Total Patients Enrolled

19 Trials studying Prostate Cancer

616 Patients Enrolled for Prostate Cancer

Karen YearyPrincipal InvestigatorRoswell Park Cancer Institute

2 Previous Clinical Trials

93 Total Patients Enrolled

Media Library

Dietary Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05764330 — N/A

Prostate Cancer Research Study Groups: Arm II (IF), Arm I (CER)

Prostate Cancer Clinical Trial 2023: Dietary Intervention Highlights & Side Effects. Trial Name: NCT05764330 — N/A

Dietary Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05764330 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for this medical research endeavor?

"Based on the clinicaltrials.gov information, this particular medical trial is not actively recruiting participants at present. Initially posted in March 12th 2023 and last updated a month later, there are presently 1109 other studies which require enrolment."

Answered by AI

What objectives is this clinical trial seeking to achieve?

"This study will measure the progression of prostate cancer over a maximum 6-month period as its chief outcome. Secondary outcomes comprise physical activity (measured through the Paffenbarger Physical Activity Questionnaire), alterations in PCa related biomarkers, and variations in urinary functionality (through an International Prostate Symptom Score)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Weight Loss Interventions to Reduce Cancer Progression in Prostate Cancer Patients Under Active Surveillance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05764330.