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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT02057536
First received: February 5, 2014
Last updated: July 26, 2017
Last verified: July 2017
  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 ER Positive Breast Cancer Taking (AI) w Joint Discomfort and Stiffness Other: Arm A Directed exercise program Other: Observation

Study Type: Interventional
Study Design: 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

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 ]
    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 ]
    compare levels pre and post levels of markers in patient's plasma by an ELISA panel from patients in both arms.


Enrollment: 30
Study Start Date: January 2014
Study Completion Date: March 2015
Primary Completion Date: March 2015 (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   (Adult, Senior)
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.

  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
Newark, Delaware, United States, 19713
Sponsors and Collaborators
Christiana Care Health Services
  More Information

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: July 26, 2017

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
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 23, 2017