Women With ER Positive Breast Cancer Taking (AI) w Joint Discomfort and Stiffness
Conditions
Keywords
estrogen receptor positive, aromatase inhibitors, exercise,
Brief summary
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.
Interventions
OTHERArm A Directed exercise program
OTHERObservation
Sponsors
Christiana Care Health Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
1\. Preexisting RA or fibromyalgia. 2. Systemic metastasis 3. ECOG performance status of greater than 2. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Disability Index | 8 weeks | directed exercise program will improve patient response to the pain disability index survey. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma levels of inflammatory markers. | 8 weeks | compare levels pre and post levels of markers in patient's plasma by an ELISA panel from patients in both arms. |
Countries
United States
Outcome results
None listed