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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

ConditionsCancer SurvivorObesityOverweightProstate AdenocarcinomaStage 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
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorRoswell Park Cancer Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Dietary Intervention

    Dietary supplement

    Receive diet plan

  • Educational Intervention

    Other intervention

    Attend educational meeting

  • Exercise Intervention

    Behavioral

    Complete exercise program

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Survey Administration

    Other intervention

    Ancillary studies

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Supportive care (diet, exercise, education)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

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 outcomes

1

Changes in muscle strength

Will be assessed by chest press, leg press, grip strength,6-minute walk test, timed-up-and-go, agility, Berg balance scale, short physical performance battery (SPPB).

Time frame
Baseline up to 6 months
2

Changes in functional capacity muscle strength

Improvement of muscle strenght

Time frame
Baseline up to 6 months
3

Change in body composition

All subjects will undergo dual-energy X-ray absorptiometry (DEXA) for measurements of body composition

Time frame
Baseline up to 6 months
4

myokines concentration

Will be assessed by serum biomarker levels.

Time frame
Baseline up to 6 months

Other outcomes

1

Serum prostate specific antigen (PSA) and androgen levels

Will evaluate the association between changes in the primary biomarkers with serum PSA and androgen levels.

Time frame
Up to 6 months
2

Adherence to nutrition and exercise advice

Adherence to advice is qualitative in nature and will be summarized using the appropriate descriptive statistics.

Time frame
Up to 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Roswell Park Cancer Institute

Lead sponsor

Source ClinicalTrials.gov
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