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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
No Placebo-Only Group
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.
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).
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 βYesβ for the criteria belowSelect...
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 βNoβ for criteria below:Select...
I have severe lung or heart conditions.
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
Changes in body composition
Secondary study objectives
Change in Respiratory Muscle Strength
Change in body composition
Change in fatigue
+7 moreOther study objectives
Adherence to nutrition and exercise advice
Serum prostate specific antigen (PSA) and androgen levels
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
410 Previous Clinical Trials
32,398 Total Patients Enrolled
Gurkamal S ChattaPrincipal InvestigatorRoswell Park Cancer Institute
3 Previous Clinical Trials
62 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a high body mass index (BMI), indicating that you are overweight or obese.You have certain orthopedic, musculoskeletal or psychological conditions that may limit your participation (decided by the doctor).I have been on hormone therapy for less than 5 years.Your doctor thinks that you are too weak or frail to participate in the study.I can walk by myself for at least 200 steps.I have been diagnosed with prostate cancer through a biopsy.The researcher thinks that you are not suitable to participate in the study for any reason.I have severe lung or heart conditions.I am on hormone therapy for cancer, possibly with chemo, immunotherapy, or radiation.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive care (diet, exercise, education)
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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