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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: May 27, 2014
Last verified: May 2014

January 15, 2010
May 27, 2014
May 2010
May 2015   (final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT01051609 on ClinicalTrials.gov Archive Site
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Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients
Prospective Study of 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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Observational
Time Perspective: Prospective
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Non-Probability Sample

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

Breast Cancer
  • 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.
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
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May 2015   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01051609
09-09-058
Yes
Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
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Principal Investigator: Sara Hurvitz, M D University of California, Los Angeles
Jonsson Comprehensive Cancer Center
May 2014

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