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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Christiana Care Health Services
Sponsor:
Information provided by (Responsible Party):
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT02057536
First received: February 5, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Women With Estrogen Receptor Positive Breast Cancer Taking Aromatase Inhibitors (AI), Who Are Experiencing Joint Discomfort and Stiffness,
Other: Arm A Directed exercise program
Other: Observation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study for the Effect of Exercise Intervention in Breast Cancer Patients With Arthralgias Receiving Aromatase Inhibitors

Resource links provided by NLM:


Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Pain Disability Index [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    directed exercise program will improve patient response to the pain disability index survey.


Secondary Outcome Measures:
  • Plasma levels of inflammatory markers. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    compare levels pre and post levels of markers in patient's plasma by an ELISA panel from patients in both arms.


Estimated Enrollment: 30
Study Start Date: January 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
8 week directed exercise program
Other: Arm A Directed exercise program
Active Comparator: Arm B
No directed exercise other than patients normal level of activity
Other: Observation

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Women over age 40 with histological evidence of hormone receptor positive breast cancer.

    2. Post- menopausal 3. Adjuvant AI therapy for at least 1 month and not more than 6 months. 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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02057536

Locations
United States, Delaware
Christiana Care/Helen F. Graham Cancer Center Recruiting
Newark, Delaware, United States, 19713
Contact: Pat Swanson, BSN    302-824-5784    pswanson@christianacare.org   
Principal Investigator: Ramya Varadarajan, MD         
Sponsors and Collaborators
Christiana Care Health Services
  More Information

No publications provided

Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT02057536     History of Changes
Other Study ID Numbers: CCC# 34006
Study First Received: February 5, 2014
Last Updated: February 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
estrogen receptor positive, aromatase inhibitors, exercise,

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014