The Effect of an Exercise Program in Breast Cancer Patients With Joint Pain While Taking Aromatase Inhibitors.

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study for the Effect of Exercise Intervention in Breast Cancer Patients With Arthralgias Receiving Aromatase Inhibitors

Conditions
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Women With ER Positive Breast Cancer Taking (AI) w Joint Discomfort and Stiffness

Intervention / Treatment
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* Other: Arm A Directed exercise program
* Other: Observation


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>8 week directed exercise program | Other: Arm A Directed exercise program<br> <br> |
| Active Comparator: Arm B<br>No directed exercise other than patients normal level of activity | Other: Observation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Disability Index | directed exercise program will improve patient response to the pain disability index survey. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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estrogen receptor positive, aromatase inhibitors, exercise,