Trial Information
Aromatase Inhibitor-Induced Arthralgia: A Proposed Management Algorithm
Inclusion Criteria:
- age greater than 18 years
- stage I-III ER+ breast cancer
- beginning adjuvant AI therapy
- post-menopausal as defined by any of the following: age >60 years, history of
bilateral oophorectomy, amenorrhea for 1 year with intact uterus and ovaries, or
serum estradiol and FSH concentrations in the post-menopausal range along with either
amenorrhea for 6 months or previous hysterectomy
Exclusion Criteria:
- previous use of an aromatase inhibitor
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Medication compliance
Outcome Description:
The primary objective of the study will be to estimate medication compliance among women with and without arthralgia with use of the proposed algorithm in those women with AIA.
Outcome Time Frame:
9 months
Safety Issue:
No
Principal Investigator
Polly Niravath, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Baylor College of Medicine
Authority:
United States: Institutional Review Board
Study ID:
AIA-001
NCT ID:
NCT01612728
Start Date:
October 2013
Completion Date:
October 2014
Related Keywords:
- Breast Cancer
- Arthralgia
- Joint Pain
- Aromatase Inhibitors
- Arthralgia
- Breast Neoplasms