Women With ER Positive Breast Cancer Taking (AI) w Joint Discomfort and Stiffness Clinical Trial
Official title:
Pilot Study for the Effect of Exercise Intervention in Breast Cancer Patients With Arthralgias Receiving Aromatase Inhibitors
| Verified date | March 2018 |
| Source | Christiana Care Health Services |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | March 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 40 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Christiana Care/Helen F. Graham Cancer Center | Newark | Delaware |
| Lead Sponsor | Collaborator |
|---|---|
| Christiana Care Health Services |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain Disability Index | directed exercise program will improve patient response to the pain disability index survey. | 8 weeks | |
| Secondary | Plasma levels of inflammatory markers. | compare levels pre and post levels of markers in patient's plasma by an ELISA panel from patients in both arms. | 8 weeks |