RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-05-02

Study Completion:2029-05-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03880422

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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

Inclusion Criteria

Exclusion Criteria

* 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

* 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

Contacts and Locations

Principal Investigator

Gurkamal S Chatta

PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Study Locations (Sites)

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

Collaborators and Investigators

Sponsor: Roswell Park Cancer Institute

Gurkamal S Chatta, PRINCIPAL_INVESTIGATOR, Roswell Park Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-02

Study Completion Date2029-05-02

Study Record Updates