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Aromatase Inhibitor-Induced Arthralgia: A Proposed Management Algorithm


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Arthralgia, Joint Pain

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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

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