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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02050906
Acronym
IDEA-P
Enrollment
32
Registered
2014-01-31
Start date
2013-05-21
Completion date
2015-07-29
Last updated
2024-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Prostate Cancer, Stage IV Prostate Cancer

Keywords

IDEA-P, Androgen Deprivation Therapy

Brief 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.

Detailed description

PRIMARY OBJECTIVES: I. To compare the effects of the intensive lifestyle intervention and standard of care treatments on functional limitations (FL), body composition (BC), and quality of life (QOL) in prostate cancer (PC) patients on androgen deprivation therapy (ADT). II. To determine the feasibility of delivering an intensive lifestyle exercise and dietary intervention to PC patients undergoing ADT. III. To identify the intermediate variables that account for the beneficial effect of the lifestyle intervention on functional limitations and QOL. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: EXERCISE COMPONENT: 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. 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. DIETARY COMPONENT: Patients undergo nutritional counseling over 30 minutes once weekly during months 1-2 and then every 2 weeks via telephone calls during month 3. ARM II: 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 undergo 2 supervised exercise training and dietary counseling sessions.

Interventions

BEHAVIORALbehavioral 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.

BEHAVIORALexercise 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.

OTHERbehavioral activity counseling

Undergo behavioral activity and nutritional counseling

BEHAVIORALtelephone based counseling

Undergo behavioral activity and nutritional counseling

PROCEDUREquality-of-life assessment

Ancillary studies

OTHERquestionnaire administration

Ancillary studies

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Ohio State University Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in FL as measured by the abbreviated Late-Life Function, Disability Inventory (LL-FDI), and Mobility-Related Self-EfficacyBaseline to up to 3 monthsExploratory analyses of the direct and indirect pathways of the intervention effects on change in FL will be conducted using a structural equation modeling longitudinal panel model approach.
Change in functional performance assessed using the 400 meter walk, stair-climb, and lift and carry taskBaseline to up to 3 months
Change in muscular strength, assessed using standardized one-repetition maximum testing protocols for chest press and leg extension exercisesBaseline to up to 3 months
Change in body composition, assessed using the Bod Pod whole-body air displacement plethysmography system and GE Lunar dual-energy X-ray absorptiometry (iDXA) systemBaseline to up to 3 months
Change in body weight, measured using a calibrated and certified balance beam scaleBaseline to up to 3 months
Change in global and disease-specific QOL assessed using the Satisfaction with Life Scale, the Short Form (SF)-36, and the Functional Assessment of Cancer Treatment-Prostate (FACT-P)Baseline to up to 3 monthsExploratory analyses of the direct and indirect pathways of the intervention effects on change in QOL will be conducted using a structural equation modeling longitudinal panel model approach.
Change in pain and fatigue, assessed using the short-form McGill Pain Questionnaire and the Brief Fatigue Inventory (BFI)Baseline to up to 3 months
Change in physical activity assessed using the Community Healthy Activities Model Program For Seniors (CHAMPS), Leisure-Time Exercise Questionnaires, and LIFECORDER Plus AccelerometerBaseline to up to 3 months
Change in exercise-related self-efficacy, assessed using Exercise Self-Efficacy, Barrier Self-Efficacy, Multi-dimensional, and Self-Regulatory Self-Efficacy scalesBaseline to up to 3 months
Change in dietary behavior using the Fred Hutchinson Food Frequency Questionnaire and three-day diet recordsBaseline to up to 3 months
Feasibility of delivering an intensive lifestyle exercise and dietary intervention, assessed using recruitment rates, intervention adherence, adverse events, and retention ratesUp to 3 monthsDescriptive statistics will be calculated prospectively throughout the trial.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026