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Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia

This study has been completed.
Information provided by (Responsible Party):
Roswell Park Cancer Institute Identifier:
First received: November 5, 2010
Last updated: April 12, 2012
Last verified: April 2012
This is a pilot study of a specifically designed exercise intervention developed for breast cancer patients with aromatase-inhibitor related joint pain.

Condition Intervention
Breast Cancer Arthralgia Behavioral: Exercising block

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia

Resource links provided by NLM:

Further study details as provided by Roswell Park Cancer Institute:

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

Enrollment: 27
Study Start Date: March 2010
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01236417

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
Principal Investigator: Tracy O'Connor, MD Roswell Park Cancer Institute
  More Information

Responsible Party: Roswell Park Cancer Institute Identifier: NCT01236417     History of Changes
Other Study ID Numbers: I 169310
Study First Received: November 5, 2010
Last Updated: April 12, 2012

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on September 21, 2017