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Completed

NCT Number: NCT01051609

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

UCLA Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

History and Physical Exam

Other

The physical exam includes vital signs and ECOG performance status.

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.

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.

Blood collection

Other

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

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
First posted
Jan 18, 2010
Registry last updated
Sep 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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