Working… Menu

Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01236417
Recruitment Status : Completed
First Posted : November 8, 2010
Last Update Posted : April 13, 2012
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:
This is a pilot study of a specifically designed exercise intervention developed for breast cancer patients with aromatase-inhibitor related joint pain.

Condition or disease Intervention/treatment Phase
Breast Cancer Arthralgia Behavioral: Exercising block Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia
Study Start Date : March 2010
Actual Primary Completion Date : March 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Exercise
Subjects will be participating in a home-based flexibility and exercise program
Behavioral: Exercising block
Exercising for 8 weeks using an elastic band

Primary Outcome Measures :
  1. Effects of exercise [ Time Frame: Length of study ]
    To assess the effect of an exercise intervention in breast cancer patients with arthralgia secondary to adjuvant treatment with aromatase inhibitors.

Secondary Outcome Measures :
  1. Feasibility of Multi-institutional study [ Time Frame: Length of the study ]
    To perform a pilot to access the feasibility of a multi-institutional approach

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Post menopausal women with a history of estrogen positive breast cancer who are receiving aromatase inhibitors for at least one month.
  • Patients must complain of mild to moderate arthralgia.
  • Ability to understand and sign informed consent.
  • Patients meet criteria for low to moderate risk for moderate exercise based oon the ACSM guidelines.

Exclusion Criteria:

  • Inability to comply with study requirements.
  • Metastatic breast cancer.
  • Patients with orthopedic or neuromuscular disorders that preclude participation in exercise.
  • Rheumatoid arthritis.
  • History of MI, angina or congestive heart failure.
  • Pregnant or lactating females.
  • Patients that are high risk for moderate exercise based on ACSM risk classification.
  • Patients who exceed minimal physical activity recommendations from the US Surgeon General's Report: Accumulation of 30 minutes or more of moderate physical activity on most days of the week.
  • Morbidly obese with BMI ≥ 40

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01236417

Layout table for location information
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
Layout table for investigator information
Principal Investigator: Tracy O'Connor, MD Roswell Park Cancer Institute

Layout table for additonal information
Responsible Party: Roswell Park Cancer Institute Identifier: NCT01236417     History of Changes
Other Study ID Numbers: I 169310
First Posted: November 8, 2010    Key Record Dates
Last Update Posted: April 13, 2012
Last Verified: April 2012
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Signs and Symptoms