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

Tracking Information

First Received Date ^ICMJE

January 15, 2010

Last Updated Date

March 4, 2013

Start Date ^ICMJE

May 2010

Estimated Primary Completion Date

May 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01051609 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

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.

Study Group/Cohort (s)

Intervention Group

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

Interventions:

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

100

Completion Date

Not Provided

Estimated Primary Completion Date

May 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01051609

Other Study ID Numbers ^ICMJE

09-09-058

Has Data Monitoring Committee

Yes

Responsible Party

Jonsson Comprehensive Cancer Center

Study Sponsor ^ICMJE

Jonsson Comprehensive Cancer Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Sara Hurvitz, M D

University of California, Los Angeles

Information Provided By

Jonsson Comprehensive Cancer Center

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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