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

Not Applicable

Completed

• Conditions: Women With ER Positive Breast Cancer Taking (AI) w Joint Discomfort and Stiffness
• Interventions: Other: Observation; Other: Arm A Directed exercise program

• Registration Number: NCT02057536
• Lead Sponsor: Christiana Care Health Services

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-05
• Study First Submitted QC: 2014-02-05
• Study First Posted: 2014-02-07
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-30
• Last Update Posted: 2018-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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.

  3. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B	Observation	No directed exercise other than patients normal level of activity
Arm A	Arm A Directed exercise program	8 week directed exercise program

Primary Outcome Measures

Name	Time	Method
Pain Disability Index	8 weeks	directed exercise program will improve patient response to the pain disability index survey.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Christiana Care/Helen F. Graham Cancer Center; 🇺🇸 Newark, Delaware, United States