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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
Must not have
Known clinically significant severe chronic obstructive pulmonary disease (COPD), ischemic heart disease, congestive heart failure, and/or significant cardiac arrhythmias
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

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 “Yes” 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe lung or heart conditions.

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
406 Previous Clinical Trials
31,497 Total Patients Enrolled
3 Trials studying Cancer Survivors
40 Patients Enrolled for Cancer Survivors
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 — N/A
Cancer Survivors Research Study Groups: Supportive care (diet, exercise, education)
Cancer Survivors Clinical Trial 2023: Dietary Intervention Highlights & Side Effects. Trial Name: NCT03880422 — N/A
Dietary Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03880422 — N/A
~14 spots leftby May 2029