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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01051609
• Other study ID #: 09-09-058
• Status: Completed
• Phase: N/A
• First received: January 15, 2010
• Last updated: September 7, 2016
• Start date: May 2010

Study information

• Verified date: September 2016
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• History and Physical Exam
The physical exam includes vital signs and ECOG performance status.
• 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.

Locations

Country	Name	City	State
United States	UCLA Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence, severity, and change in severity of pain based on joint exam and joint ultrasound inflammatory score.		Study visits at 3, 6, 9 and 12 months after the start of treatment with an Aromatase Inhibitor	No