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Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01236417
First Posted: November 8, 2010
Last Update Posted: April 13, 2012
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.
Information provided by (Responsible Party):
Roswell Park Cancer Institute
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01236417


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

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01236417     History of Changes
Other Study ID Numbers: I 169310
First Submitted: November 5, 2010
First Posted: November 8, 2010
Last Update Posted: April 13, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Breast Neoplasms
Arthralgia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms