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Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01236417
First received: November 5, 2010
Last updated: April 12, 2012
Last verified: April 2012
History of Changes
  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: Open Label
Primary Purpose: Prevention
Official Title: Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Effects of exercise [ Time Frame: Length of study ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01236417     History of Changes
Other Study ID Numbers: I 169310
Study First Received: November 5, 2010
Last Updated: April 12, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013