Text Size

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
History of Changes
  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:

U.S. FDA Resources

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 May 16, 2013