The Intensive Diet and Exercise Adherence Trial - Pilot (IDEA-P): A Feasibility Study of a Lifestyle Intervention in Men Undergoing Androgen Deprivation Therapy

Status: Active, not recruiting
Location: See location...
Intervention Type: Behavioral, Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Healthy Volunteers: No
View:

• Diagnosed with PC: histologically-defined diagnosis of PC based upon providing pathology reports and staging studies

• Initiating ADT: will be initiating a planned course of at least 3 months of ADT; the ADT is defined as: (a) surgical castration; (b) gonadotropin-releasing hormone (GNRH) antagonist alone; (c) GNRH antagonist with oral androgen receptor blockade, and (d) GNRH antagonist, oral androgen receptor blockade, and 5-alpha reductase inhibitors; we will not include men with only oral antiandrogen therapy such as 5-alpha reductase inhibitors alone or oral antiandrogens alone, as they do not produce castrate levels of testosterone

• Stage: at enrollment, all men have stage IV disease, which is our major presentation to the medical oncology prostate program; two groups are typical; the first involves men who usually present for initial diagnosis with minimally metastatic disease and elevated prostate-specific antigen (PSA) and staging studies with modest nodal enlargement or bone lesions, typically asymptotic; the second group involves men we have been monitoring after local therapy, surgery or radiation, but who have a slow rise in PSA indicating failure of curative therapy; at some point in time asymptomatic metastases are noted on scans, and ADT is offered

• Sedentary lifestyle: fewer than 60 minutes of participation in structured moderate intensity physical activity each week

• Health status: all participants must be free of active cardiovascular disease (CVD), unstable angina, arrhythmia, or severe systemic disease that would make moderate intensity exercise participation unsafe; men with prior CVD that have had successful intervention/treatment that are no longer have active CVD and are medically cleared to safely exercise by their physician will be eligible to participate in the study

• Consents: willing to give an informed consent and sign a Health Insurance Portability and Accountability Act (HIPPA) authorization form

• Physician medical clearance: all men will have medical clearance to participate in the study from a board certified internist, primary care physician, or cardiologist (for men with ongoing cardiovascular disease) prior to inclusion in the study; all participants' treating oncologists will also provide consent for participation prior to inclusion in the study

Locations
United States
Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus
Time Frame
Start Date: May 21, 2013
Estimated Completion Date: December 31, 2022
Participants
Target number of participants: 32
Treatments
Experimental: Arm I (diet and exercise intervention)
EXERCISE COMPONENT: Patients undergo 1 hour of monitored 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. All patients will complete a comprehensive exercise and quality-of-life assessment at baseline, month 2 and month 3.~BEHAVIORAL ACTIVITY COUNSELING: Patients undergo behavioral activity counseling in small group sessions over 20 minutes once weekly during months 1-2 and individualized activity counseling via telephone calls over 20 minutes every 2 weeks for 3 months. Counseling will include questionnaire administration.~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.
Active Comparator: Arm II (standard of care)
TELEPHONE BASED COUNSELING: Patients receive standard care and educational literature describing the American Institute of Cancer Research dietary and physical activity guidelines. Patients also receive phone calls over 20 minutes every 2 weeks for 3 months focusing on routine prostate cancer self-management. After 3 months, patients have the option to undergo 2 supervised exercise training and dietary counseling sessions. All patients will complete a comprehensive exercise and quality-of-life assessment at baseline, month 2 and month 3.
Authors
Brian Focht
Related Therapeutic Areas
Sponsors
Leads: Ohio State University Comprehensive Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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