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

A Pilot Study of Physical Activity for Improving Quality of Life in Prostate Cancer Patients on Androgen Deprivation Therapy

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: walking exercise; Behavioral: weight training; Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: aerobic exercise; Subjects who are randomly assigned to this arm will be assigned a walking program to participate in 3 times a week for eight weeks	Behavioral: walking exercise; Subjects will be given an exercise prescription for walking 3 times a week for eight weeks
Experimental: resistence training; 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	Behavioral: weight training; participants will be given a weight training prescription to do 3 times a week for eight weeks.
Active Comparator: Usual Care; Subjects who are randomly assigned to this arm will not participate in any exercise program and will continue with usual care treatment	Behavioral: Usual Care; Subjects in this arm will continue with their usual care and not start any exercise program for eight weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility of recruiting 60 men with prostate CA on ADT to an ex intervention study w/ three arms. To determine if an ex prgm provides symptom mgt as compared to usual care,if resistance training provides symptom mgt not obtained from aerobic ex alone.	8 weeks

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Kathleen Y Wolin, ScD, Washington University School of Medicine in Saint Louis

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2008
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: February 27, 2009
• First Submitted That Met QC Criteria: February 27, 2009
• First Posted (Estimate): March 2, 2009

Study Record Updates

• Last Update Posted (Actual): May 7, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: prostate cancer; aerobic exercise; resistance training
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 08-0318