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RecruitingInterventional

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

NCT ID: NCT03880422Sponsor: Roswell Park Cancer InstituteLast updated: 2026-05-07

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.

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.

Arms & 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

Outcome measures

Primary

  • Changes in body composition

    Will be measured by dual X-ray absorptiometry (DXA) total body and regional lean mass, fat mass and % body fat.

    Time frame: Baseline up to 6 months

Secondary

  • 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

Sex: MaleAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263

Recruiting
Ellis Levine, MD · Contact
716-845-3159Ellis.Levine@roswellpark.org
Ellis Levine, MD · Principal Investigator