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Nutrition and Exercise Interventions for Androgen Deprivation Therapy-Induced Obese Frailty in Elderly and Non-Elderly Survivors of Advanced Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether personal nutrition and exercise advice can reduce excess body fat and physical weakness linked to androgen deprivation therapy (ADT), a hormone treatment for prostate cancer. It is for people with prostate cancer who are prescribed or receiving ADT. It also looks at changes in blood levels of myokines, substances made by muscles.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have prostate adenocarcinoma, a type of prostate cancer, confirmed by a tissue sample. Any stage or grade is allowed.
  • Be prescribed continuous ADT or have received it for less than 5 years.
  • Have hemoglobin, a protein in red blood cells, above 11 g/dL.
  • Within 6 months before joining, have creatinine, a kidney test, below 1.5 times the upper normal limit and AST or ALT, liver tests, below 2 times that limit.
  • Have liver function tests below 2 times the upper normal limit.
  • Be able to walk at least 100 meters (about 200 steps) without help, or have an ECOG activity score of 0 or 1, meaning fully active or limited only in hard physical activity.
  • Have no health reason that makes any study activity, including aerobic exercise, unsafe.
  • Be able to read, write, and understand English, understand that this is research, and sign an approved consent form before any study procedures.

Who can't join

  • Have serious chronic obstructive pulmonary disease (COPD), a long-term lung disease; heart disease from poor blood flow; heart failure; or major heartbeat problems.
  • Have bone, joint, muscle, or mental health problems that limit participation, as judged by the clinician.
  • Be too medically frail, as judged by the clinician.
  • Have a condition that makes extra blood draws beyond usual care unsafe.
  • Be unwilling or unable to follow the study rules.
  • Have any other condition that the study doctor thinks makes the study treatment unsuitable.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 Exclusion Criteria: * 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

Study sites (1)

NY