A Pilot Study of Physical Activity for Improving Quality of Life in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT) (MAP-P)

The Washington University

Status: Completed

Conditions: Prostate Cancer

Treatments: Behavioral: walking exercise; Behavioral: weight training; Behavioral: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT00853164

08-0318

Details and patient eligibility

About

60 eligible subjects will be randomized into one of three study arms 1) aerobic exercise, 2) resistance exercise, or 3) usual care. Baseline measurements will be done on all study subjects, these measurements include: height, weight, dual energy x-ray absorptiometry (DXA) for bone mineral density and lean body mass measurements, blood will be taken to measure serum free testosterone, prostate-specific antigen (PSA), glucose, and insulin levels. Fitness will also be evaluated using a graded exercise test. Questionnaires on health and personal history will also be completed. Men randomized to the aerobic exercise treatment arm will participate in a walking program three times a week for eight weeks. The participants will start at 15 minutes per session and increase to a goal of 60 minutes per session. Men randomized to the resistance training treatment arm will participate in an eight-week program of eight strength training exercises three times per week. Men in the usual care arm will receive written materials from the American Cancer Society about coping with cancer, which includes information about participation in physical activity. At the end of the eight week intervention participants in all three study arms will complete the same questionnaires and measurements they completed at baseline.

Enrollment: 8 patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men with metastatic prostate cancer receiving ADT and men who have failed primary therapy and are receiving ADT.
• Men from the radiology practice who are receiving ADT as neoadjuvant therapy to primary radiotherapy (enrolled only following completion of primary radiotherapy).

Exclusion criteria

• Men with the following counter-indications to exercise:

  • Lower limb, bone, muscle, or joint pathology of a severity which limits their ability to be physically active.
  • A history of significant cardiac disease using criteria established by the American College of Sports Medicine ( Criteria: pain, discomfort in the chest, neck, jaw, arms, or other areas that may be due to ischemia; shortness of breath at rest or with mild exertion; ankle edema; palpitations or tachycardia; known heart murmur; unusual fatigue or shortness of breath with usual activities' syncope)
  • Other medical contraindications which would compromise participation in a lifestyle physical activity program.
  • Those who are currently physically active

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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8 participants in 3 patient groups

aerobic exercise

Experimental group

Description:

Subjects who are randomly assigned to this arm will be assigned a walking program to participate in 3 times a week for eight weeks

Treatment:

Behavioral: walking exercise

resistence training

Experimental group

Description:

Subjects who are randomly assigned to this arm will be assigned a weight training program to participate in 3 times a week for eight weeks

Treatment:

Behavioral: weight training

Usual Care

Active Comparator group

Description:

Subjects who are randomly assigned to this arm will not participate in any exercise program and will continue with usual care treatment

Treatment:

Behavioral: Usual Care