The Effect of an Exercise Program in Breast Cancer Patients With Joint Pain While Taking Aromatase Inhibitors.
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.
Women With Estrogen Receptor Positive Breast Cancer Taking Aromatase Inhibitors (AI), Who Are Experiencing Joint Discomfort and Stiffness,
Other: Arm A Directed exercise program
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Pilot Study for the Effect of Exercise Intervention in Breast Cancer Patients With Arthralgias Receiving Aromatase Inhibitors|
- Pain Disability Index [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]directed exercise program will improve patient response to the pain disability index survey.
- Plasma levels of inflammatory markers. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]compare levels pre and post levels of markers in patient's plasma by an ELISA panel from patients in both arms.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02057536
|United States, Delaware|
|Christiana Care/Helen F. Graham Cancer Center||Recruiting|
|Newark, Delaware, United States, 19713|
|Contact: Pat Swanson, BSN 302-824-5784 firstname.lastname@example.org|
|Principal Investigator: Ramya Varadarajan, MD|