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

Obesity Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Cancer Survivor
  • Frailty
  • Obesity
  • Overweight
  • Prostate Adenocarcinoma
  • Prostatic Neoplasms
  • Stage A Prostate Cancer
  • Stage B Prostate Cancer
  • Stage C Prostate Cancer
  • Stage D Prostate Cancer
  • Stage I Prostate Cancer
  • Stage II Prostate Cancer
  • Stage IIA Prostate Cancer
  • Stage IIB Prostate Cancer
  • Stage IIC Prostate Cancer
  • Stage III Prostate Cancer
  • Stage IIIA Prostate Cancer
  • Stage IIIB Prostate Cancer
  • Stage IIIC Prostate Cancer
  • Stage IV Prostate Cancer
  • Stage IVA Prostate Cancer
  • Stage IVB Prostate Cancer
Clinical Trial Details
NCT number NCT03880422
Study type Interventional
Source Roswell Park Cancer Institute
Contact
Status Recruiting
Phase N/A
Start date May 2, 2019
Completion date May 2, 2029
View Details
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