Trials / Recruiting
RecruitingNCT03880422
Nutrition and Exercise Interventions in Reducing Androgen Deprivation Therapy-Induced Obese Frailty in Prostate Cancer Survivors
Nutrition and Exercise Interventions to Reduce Androgen Deprivation Therapy-Induced Obese Frailty in Survivors of Advanced Prostate Cancer
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Roswell Park Cancer Institute · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2019-05-02
- Primary completion
- 2029-05-02
- Completion
- 2029-05-02
- First posted
- 2019-03-19
- Last updated
- 2026-04-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03880422. Inclusion in this directory is not an endorsement.