Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01051609
First received: January 15, 2010
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to compare pre and post Aromatase Inhibitor (AI) treatment serological markers of inflammation and assess for correlation with AI-MS.


Condition Intervention
Breast Cancer
Other: History and Physical Exam
Other: Grip Strength Measurement
Behavioral: Surveys
Other: Blood Collection
Procedure: Ultrasound of Hand/Wrist

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Study of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Presence, severity, and change in severity of pain based on joint exam and joint ultrasound inflammatory score. [ Time Frame: Study visits at 3, 6, 9 and 12 months after the start of treatment with an Aromatase Inhibitor ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2010
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Intervention Group
There is only one arm in this trial. Please see interventions for more detailed descriptions.
Other: History and Physical Exam
The physical exam includes vital signs and ECOG performance status.
Other: Grip Strength Measurement
A hand grip strength test will be used to measure and compare baseline and post-AI treatment forearm muscle strength in each hand.
Behavioral: Surveys
Self-administered surveys including Health Assessment Questionnaire Disability Index, CES-D, FACIT-F, PSQI, GAD7, number of minutes of morning stiffness, and questions pertaining to vasomotor symptoms will be used in this study to assess for presence, severity, characteristics, and associations of AI-associated musculoskeletal symptoms.
Other: Blood Collection
A set of blood markers will be assayed at baseline, 6 months, and 12 months.
Procedure: Ultrasound of Hand/Wrist
An inflammatory arthritis ultrasound scoring method similar to the RAMRIS scoring system used in rheumatoid arthritis, will evaluate joints in the most affected hand and wrist at 6 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women 18 years and older with non-metastatic hormone receptor (ER and/or PR) positive breast cancer who are eligible for and planning on starting treatment with an AI within one month of signing consent

Criteria

Inclusion Criteria:

  • Women 18 years and older with non-metastatic hormone receptor (ER and/or PR) positive breast cancer who are eligible for and planning on starting treatment with an AI within one month of signing consent.
  • Postmenopausal, defined as at least one of the following: a) amenorrhea for at least 12 months b) prior bilateral oophorectomy at least 2 years prior to trial registration.

Exclusion Criteria:

  • History of autoimmune connective tissue disease, such as rheumatoid arthritis, lupus, or other autoimmune conditions affecting joints.
  • Treatment with steroid (for any condition, except for chemotherapy premedication) within 30 days of trial registration.
  • Prior treatment with an AI (patients previously or currently on tamoxifen are eligible as long as patients are off tamoxifen for 2 weeks prior to baseline blood draw)
  • Active or ongoing infection
  • Known metastatic disease
  • Known history of HIV or hepatitis infections
  • Ongoing radiation therapy (radiation must have been completed 2 weeks prior to starting treatment with an AI)
  • Non-invasive (DCIS, LCIS) cancer only (no diagnosis of invasive cancer)
  • Pregnant or lactating
  • Unable to speak, read, and write in English
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01051609

Locations
United States, California
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Sara Hurvitz, M D University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01051609     History of Changes
Other Study ID Numbers: 09-09-058
Study First Received: January 15, 2010
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Jonsson Comprehensive Cancer Center:
Post Menopausal
Breast Cancer

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 April 17, 2014