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Nutrition and Exercise Advice for Prostate Cancer

N/A
Recruiting
Led By Gurkamal S Chatta
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
Prescribed or already receiving continuous ADT for < 5 years
Able to walk unassisted at least 100 meters (200 steps) or ECOG <= 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Study Summary

This trial looks at whether giving nutrition and exercise advice to prostate cancer patients who are on androgen deprivation therapy can help to reduce obese frailty and change the levels of myokines in blood.

Who is the study for?
This trial is for prostate cancer survivors who are overweight or obese and have been on androgen deprivation therapy for less than 5 years. They must be able to walk, have normal liver function, not be receiving other cancer treatments like chemo, and can't have severe heart or lung conditions.Check my eligibility
What is being tested?
The study tests if personalized nutrition advice and exercise programs can reduce obesity-related weakness in men treated with hormone therapy for prostate cancer. It also looks at changes in blood levels of muscle-related proteins (myokines).See study design
What are the potential side effects?
Since the interventions involve diet and exercise adjustments rather than medications, side effects may include typical exercise-related issues such as muscle soreness or strain. Dietary changes might cause digestive alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check β€œYes” for the criteria below
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I have been on hormone therapy for less than 5 years.
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I can walk by myself for at least 200 steps.
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I have been diagnosed with prostate cancer through a biopsy.

Timeline

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
Changes in body composition
Secondary outcome measures
Change in Respiratory Muscle Strength
Change in body composition
Change in fatigue
+7 more
Other outcome measures
Adherence to nutrition and exercise advice
Serum prostate specific antigen (PSA) and androgen levels

Trial Design

1Treatment groups
Experimental Treatment
Group I: Supportive care (diet, exercise, education)Experimental Treatment5 Interventions
Patients receive an individualized diet plan for 6 months. Patients complete an individualized home-based exercise program aerobic and resistance exercise over 10-30 minutes per day, at minimum 3 days per week for 6 months, and a progressive resistance exercise program including an individually tailored prescription targeting the chest, shoulders, arms, and leg musculature for 1-4 sets of 10-15 repetitions, 5 days per week over 6 months. Patients also attend monthly educational meetings for 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise Intervention
2016
Completed Phase 4
~1330
Dietary Intervention
2014
Completed Phase 2
~2550

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
31,077 Total Patients Enrolled
Gurkamal S ChattaPrincipal InvestigatorRoswell Park Cancer Institute
3 Previous Clinical Trials
62 Total Patients Enrolled

Media Library

Dietary Intervention Clinical Trial Eligibility Overview. Trial Name: NCT03880422 β€” N/A
Prostate Adenocarcinoma Research Study Groups: Supportive care (diet, exercise, education)
Prostate Adenocarcinoma Clinical Trial 2023: Dietary Intervention Highlights & Side Effects. Trial Name: NCT03880422 β€” N/A
Dietary Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03880422 β€” 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 current openings in this trial to join?

"Affirmative. According to the clinicaltrials.gov records, this medical trial is still searching for participants since its initial post on April 4th 2019 and last updated on May 3rd 2022. One facility requires 30 patients to partake in the study."

Answered by AI

How many participants is this research endeavor currently involving?

"Affirmative. According to records on clinicaltrials.gov, this medical trial was first posted on April 4th 2019 and is actively looking for participants. 30 patients need to be recruited from one site alone."

Answered by AI
~5 spots leftby May 2025