Intensive Diet and Exercise or Standard of Care in Improving Physical Function and Quality of Life in Patients With Prostate Cancer Undergoing Androgen Deprivation Therapy
NCT02050906 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2024-12-31
Summary
This randomized pilot clinical trial studies intensive diet and exercise or standard of care in improving physical function and quality of life in patients with prostate cancer undergoing androgen deprivation therapy. Diet and exercise may help improve physical function and quality of life in prostate cancer patients. It is not yet known whether intensive diet and exercise is more effective than standard of care in improving physical function and quality of life in patients with prostate cancer undergoing androgen deprivation therapy.
Conditions
- Recurrent Prostate Cancer
- Stage IV Prostate Cancer
Interventions
- BEHAVIORAL
-
behavioral dietary intervention
Patients undergo nutritional counseling over 30 minutes once weekly during months 1-2 and then every 2 weeks via telephone calls during month 3.
- BEHAVIORAL
-
exercise intervention
Patients undergo 1 hour of intensive exercise comprising 30 minutes of aerobic exercise and 30 minutes of resistance exercise twice weekly during weeks 1-6, once weekly during weeks 7-8, and independently during weeks 7-12.
- OTHER
-
behavioral activity counseling
Undergo behavioral activity and nutritional counseling
- BEHAVIORAL
-
telephone based counseling
Undergo behavioral activity and nutritional counseling
- PROCEDURE
-
quality-of-life assessment
Ancillary studies
- OTHER
-
questionnaire administration
Ancillary studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Ohio State University Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
Brian Focht, PhD · Ohio State University Comprehensive Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-05-21
- Primary Completion
- 2015-07-29
- Completion
- 2015-07-29
Countries
- United States
Study Locations
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