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RecruitingNot ApplicableNCT03880422

Nutrition and Exercise Interventions in Reducing Androgen Deprivation Therapy-Induced Obese Frailty in Prostate Cancer Survivors

Nutrition and Exercise Interventions to Reduce Androgen Deprivation Therapy-Induced Obese Frailty in Survivors of Advanced Prostate Cancer

Sponsor

Roswell Park Cancer Institute

Enrollment

50 participants

Start Date

May 2, 2019

Study Type

INTERVENTIONAL

Conditions

ObesityProstate AdenocarcinomaCancer SurvivorOverweightStage A Prostate CancerStage B Prostate CancerStage C Prostate CancerStage D Prostate CancerStage I Prostate CancerStage II Prostate CancerStage IIA Prostate CancerStage IIB Prostate CancerStage IIC Prostate CancerStage III Prostate CancerStage IIIA Prostate CancerStage IIIB Prostate CancerStage IIIC Prostate CancerStage IV Prostate CancerStage IVA Prostate CancerStage IVB Prostate Cancer

Summary

This trial studies how well nutrition and exercise interventions work in reducing androgen deprivation therapy-induced obese frailty in prostate cancer survivors. Individualized nutrition and exercise advice for prostate cancer patients on androgen deprivation therapy may help to reduce obese frailty and change the levels of myokines in blood.

Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria9

  • Biopsy-confirmed prostate adenocarcinoma of any stage/grade
  • 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 Criteria6

  • Known clinically significant severe chronic obstructive pulmonary disease (COPD), ischemic heart disease, congestive heart failure, and/or significant cardiac arrhythmias
  • 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

Interventions

DIETARY_SUPPLEMENTDietary Intervention

Receive diet plan

OTHEREducational Intervention

Attend educational meeting

BEHAVIORALExercise Intervention

Complete exercise program

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERSurvey Administration

Ancillary studies

Locations(1)

Roswell Park Cancer Institute

Buffalo, New York, United States

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NCT03880422

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