Nutrition and Exercise Interventions in Reducing Androgen Deprivation Therapy-Induced Obese Frailty in Prostate Cancer Survivors
NCT ID: NCT03880422
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2019-05-02
2029-05-02
Brief Summary
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Detailed Description
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I. Assess the effect of individualized nutrition and exercise counseling interventions on myokine expression and body composition in prostate cancer (PrCa) patients being treated with androgen deprivation therapy (ADT).
SECONDARY OBJECTIVES:
I. Determine any changes in muscle strength, respiratory muscle strength and functional capacity resulting from the nutrition and exercise counseling interventions.
II. Determine any changes in myokines, circulating inflammatory and frailty-associated cytokines resulting from the nutrition and exercise counseling interventions.
III. Determine the effect of the study interventions on dietary intake, physical activity, fatigue, and quality of life.
EXPLORATORY OBJECTIVES:
I. Correlate changes in secondary objectives with prostate specific antigen (PSA) and testosterone levels.
II. Evaluate adherence to nutrition and exercise advice. III. Evaluate assessment tools and recruiting strategies.
OUTLINE:
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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Supportive care (diet, exercise, education)
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.
Dietary Intervention
Receive diet plan
Educational Intervention
Attend educational meeting
Exercise Intervention
Complete exercise program
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Ancillary studies
Interventions
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Dietary Intervention
Receive diet plan
Educational Intervention
Attend educational meeting
Exercise Intervention
Complete exercise program
Quality-of-Life Assessment
Ancillary studies
Survey Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prescribed or already receiving continuous ADT for \< 5 years
* Hemoglobin \> 11 g/dL
* Creatinine \< 1.5 x upper limit of normal (ULN), AST or ALT \<2 x ULN within 6 months prior to enrollment
* Liver function tests \< 2 x ULN
* Able to walk unassisted at least 100 meters (200 steps) or ECOG \<= 1
* No contraindications to any aspect of participation, including aerobic exercise
* Participant must be able to read, write, and understand the English language and be able to provide written consent
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria
* Limiting orthopedic, musculoskeletal or psychological conditions (clinician discretion)
* Overall medical frailty (clinician discretion)
* Any condition contraindicating additional blood collection beyond standard of care
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study intervention
18 Years
MALE
No
Sponsors
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Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Gurkamal S Chatta
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Facility Contacts
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Other Identifiers
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NCI-2019-00341
Identifier Type: REGISTRY
Identifier Source: secondary_id
I 72118
Identifier Type: OTHER
Identifier Source: secondary_id
I 72118
Identifier Type: -
Identifier Source: org_study_id
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