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

Christiana Care Health Services

Status: Completed

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

Treatments: Other: Arm A Directed exercise program; Other: Observation

Study type: Interventional

Funder types: Other

Identifiers

NCT02057536

CCC# 34006

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Arm A

Experimental group

Description:

8 week directed exercise program

Treatment:

Other: Arm A Directed exercise program

Arm B

Active Comparator group

Description:

No directed exercise other than patients normal level of activity

Treatment:

Other: Observation