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

NCT01051609 | Completed DMC

• 1 other identifier: 09-09-058
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Post Menopausal; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Intervention Group

There is only one arm in this trial. Please see interventions for more detailed descriptions.

Other: History and Physical Exam; Other: Grip Strength Measurement; Behavioral: Surveys; Other: Blood Collection; Procedure: Ultrasound of Hand/Wrist

Interventions

History and Physical Exam OTHER

The physical exam includes vital signs and ECOG performance status.

Intervention Group

Grip Strength Measurement OTHER

A hand grip strength test will be used to measure and compare baseline and post-AI treatment forearm muscle strength in each hand.

Intervention Group

Surveys BEHAVIORAL

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.

Intervention Group

Blood Collection OTHER

A set of blood markers will be assayed at baseline, 6 months, and 12 months.

Intervention Group

Ultrasound of Hand/Wrist PROCEDURE

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

UCLA Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Health Records, Personal; Restraint, Physical; Surveys and Questionnaires; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Behavior Control; Therapeutics; Immobilization; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• Sara Hurvitz, M D

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2010
• First Posted: January 18, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2013
• Last Updated: September 9, 2016

Record last verified: 2016-09

Locations

US (1)