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

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ClinicalTrials.gov Identifier: NCT02057536
Recruitment Status : Completed
First Posted : February 7, 2014
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Christiana Care Health Services

Study Description
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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.


Condition or disease Intervention/treatment Phase
Women With ER Positive Breast Cancer Taking (AI) w Joint Discomfort and Stiffness Other: Arm A Directed exercise program Other: Observation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study for the Effect of Exercise Intervention in Breast Cancer Patients With Arthralgias Receiving Aromatase Inhibitors
Study Start Date : January 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Pain Disability Index [ Time Frame: 8 weeks ]
    directed exercise program will improve patient response to the pain disability index survey.


Secondary Outcome Measures :
  1. Plasma levels of inflammatory markers. [ Time Frame: 8 weeks ]
    compare levels pre and post levels of markers in patient's plasma by an ELISA panel from patients in both arms.


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes 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. 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057536


Locations
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United States, Delaware
Christiana Care/Helen F. Graham Cancer Center
Newark, Delaware, United States, 19713
Sponsors and Collaborators
Christiana Care Health Services
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT02057536    
Other Study ID Numbers: CCC# 34006
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Keywords provided by Christiana Care Health Services:
estrogen receptor positive, aromatase inhibitors, exercise,
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases