Nutrition and Exercise Interventions for Androgen Deprivation Therapy-Induced Obese Frailty in Elderly and Non-Elderly Survivors of Advanced Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dietary Intervention, Educational Intervention, Exercise Intervention, Quality-of-Life Assessment.
- Who it may be relevant to
- Registry conditions: Cancer Survivor, Obesity, Overweight, Prostate Adenocarcinoma. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
PRIMARY OBJECTIVES:
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.
Interventions
- Dietary supplement Dietary Intervention
Receive diet plan - Other Educational Intervention
Attend educational meeting - Behavioral Exercise Intervention
Complete exercise program - Other Quality-of-Life Assessment
Ancillary studies - Other Survey Administration
Ancillary studies
Primary outcome measures
- Changes in body composition [Time frame: Baseline up to 6 months]
Secondary outcome measures (10)
- Changes in muscle strength [Time frame: Baseline up to 6 months]
- Changes in functional capacity muscle strength [Time frame: Baseline up to 6 months]
- Change in body composition [Time frame: Baseline up to 6 months]
- myokines concentration [Time frame: Baseline up to 6 months]
- cytokines concentration [Time frame: Baseline up to 6 months]
- Health related quality of life Short Form [Time frame: Up to 6 months]
- Changes in dietary intake [Time frame: Baseline up to 6 months]
- Changes in physical activity [Time frame: Baseline up to 6 months]
- Change in fatigue [Time frame: Baseline up to 6 months]
- Change in Respiratory Muscle Strength [Time frame: Baseline up to 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Roswell Park Cancer Institute — Buffalo
Identifiers
NCT: NCT03880422 · I 72118 · NCI-2019-00341 · I 72118