Supportive Therapy in Androgen Deprivation Clinic in Improving Health Outcomes and Managing Side Effects in Patients With Prostate Cancer
NCT02168062 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57
Last updated 2020-07-23
Summary
This pilot partially-randomized phase II trial studies how well Supportive Therapy in Androgen Deprivation (STAND) clinic works in improving health outcomes and managing side effects in patients with prostate cancer. Individualized counseling regarding exercise and dietary habits may help improve patient understanding, satisfaction, and overall lessen adverse impact on quality of life caused by androgen deprivation.
Conditions
- Prostate Adenocarcinoma
Interventions
- BEHAVIORAL
-
Behavioral Dietary Intervention
Receive individualized nutrition counseling
- OTHER
-
Counseling
Receive individualized symptom management service counseling
- OTHER
-
Educational Intervention
Review educational modules
- BEHAVIORAL
-
Exercise Intervention
Receive individualized exercise counseling
- DRUG
-
Goserelin Acetate
Given SC
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- DRUG
-
Leuprolide Acetate
Given SC or IM
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- DRUG
-
Triptorelin Pamoate
Given IM
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Rahul Aggarwal, MD · University of California, San Francisco
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-06-16
- Primary Completion
- 2018-05-22
- Completion
- 2018-05-22
- FDA Drug
- Yes
Countries
- United States
Study Locations
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