Back to resultsExercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia
Primary Purpose
Breast Cancer, Arthralgia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercising block
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer
Eligibility 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
Sites / Locations
- Roswell Park Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise
Arm Description
Subjects will be participating in a home-based flexibility and exercise program
Outcomes
Primary Outcome Measures
Effects of exercise
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
To perform a pilot to access the feasibility of a multi-institutional approach
Full Information
NCT ID
NCT01236417
First Posted
November 5, 2010
Last Updated
April 12, 2012
Sponsor
Roswell Park Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT01236417
Brief Title
Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia
Official Title
Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a pilot study of a specifically designed exercise intervention developed for breast cancer patients with aromatase-inhibitor related joint pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Arthralgia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Subjects will be participating in a home-based flexibility and exercise program
Intervention Type
Behavioral
Intervention Name(s)
Exercising block
Intervention Description
Exercising for 8 weeks using an elastic band
Primary Outcome Measure Information:
Title
Effects of exercise
Description
To assess the effect of an exercise intervention in breast cancer patients with arthralgia secondary to adjuvant treatment with aromatase inhibitors.
Time Frame
Length of study
Secondary Outcome Measure Information:
Title
Feasibility of Multi-institutional study
Description
To perform a pilot to access the feasibility of a multi-institutional approach
Time Frame
Length of the study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy O'Connor, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia
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