The Effect of an Exercise Program in Breast Cancer Patients With Joint Pain While Taking Aromatase Inhibitors.
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|ClinicalTrials.gov Identifier: NCT02057536|
Recruitment Status : Completed
First Posted : February 7, 2014
Last Update Posted : April 2, 2018
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The objective of this study is to determine if patients taking aromatase inhibitors (AI), who are experiencing joint discomfort and stiffness, would have reduction in this discomfort and stiffness by participating in a directed exercise program. The overarching objective is to improve patient compliance with the medication and ultimately clinical outcome.
In this pilot study, we will utilize a scientific approach for proof of concept employing both objective (inflammatory cytokine profiles and Physical Therapy (PT) measurements) and subjective (patient perception) methods to support an evidence based clinical plan. Patients will be divided into two cohorts. Group A will receive AI therapy with a directed exercise program. Group B will receive AI therapy without a directed exercise program. Data will be collected when both cohorts of patients enroll in the study, at the end of PT for Group A and, at the end of 8 weeks for Group B. At these time points, both groups will undergo a PT evaluation; have blood drawn for cytokine profiles; answer questions on an iPad that includes: the Pain Disability Index, the PHQ-4 (Psycological Health Questionaire depression scale, and pain level scale.
|Condition or disease||Intervention/treatment||Phase|
|Women With ER Positive Breast Cancer Taking (AI) w Joint Discomfort and Stiffness||Other: Arm A Directed exercise program Other: Observation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Pilot Study for the Effect of Exercise Intervention in Breast Cancer Patients With Arthralgias Receiving Aromatase Inhibitors|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Experimental: Arm A
8 week directed exercise program
Other: Arm A Directed exercise program
Active Comparator: Arm B
No directed exercise other than patients normal level of activity
- Pain Disability Index [ Time Frame: 8 weeks ]directed exercise program will improve patient response to the pain disability index survey.
- Plasma levels of inflammatory markers. [ Time Frame: 8 weeks ]compare levels pre and post levels of markers in patient's plasma by an ELISA panel from patients in both arms.
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|Ages Eligible for Study:||40 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
1. Women over age 40 with histological evidence of hormone receptor positive breast cancer.
2. Post- menopausal 3. Adjuvant AI therapy. 4. Significant joint discomfort/stiffness when attempting activities of daily living which began or significantly increased after initiation of AI therapy.
5. Currently not in an active directed exercise program (>60 minutes 2x/wk)
1. Preexisting RA or fibromyalgia. 2. Systemic metastasis 3. ECOG performance status of greater than 2.
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): NCT02057536
|United States, Delaware|
|Christiana Care/Helen F. Graham Cancer Center|
|Newark, Delaware, United States, 19713|
|Responsible Party:||Christiana Care Health Services|
|Other Study ID Numbers:||
|First Posted:||February 7, 2014 Key Record Dates|
|Last Update Posted:||April 2, 2018|
|Last Verified:||March 2018|
estrogen receptor positive, aromatase inhibitors, exercise,
Neoplasms by Site