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Women With ER Positive Breast Cancer Taking (AI) w Joint Discomfort and Stiffness | The Effect of an Exercise Program in Breast Cancer Patients With Joint Pain While Taking Aromatase Inhibitors.

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

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

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

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Arm A Directed exercise program

Other:Observation

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Arm A8 week directed exercise program

Arm BNo directed exercise other than patients normal level of activity

Study Status

Completed

Start Date: January 2014

Completed Date: March 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Pain Disability Index

Secondary Outcome: Plasma levels of inflammatory markers.

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Christiana Care Health Services

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02057536

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