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NCT03880422 | RECRUITING | Cancer Survivor

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

Roswell Park Cancer Institute

Brief 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.

Condition or disease

Cancer Survivor

Obesity

Overweight

Prostate Adenocarcinoma

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

Intervention/treatment

Dietary Intervention

Educational Intervention

Exercise Intervention

Quality-of-Life Assessment

Survey Administration

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Nutrition and Exercise Interventions to Reduce Androgen Deprivation Therapy-Induced Obese Frailty in Survivors of Advanced Prostate Cancer
Actual Study Start Date : 2019-05-02
Estimated Primary Completion Date : 2029-05-02
Estimated Study Completion Date : 2029-05-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
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
Nutrition and Exercise Interventions in Reducing Androgen Deprivation Therapy-Induced Obese Frailty in Prostate Cancer Survivors

Location Details

NCT03880422

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Locations

RECRUITING

United States, New York

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263