ClinicalTrials.Veeva

Menu

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

Jonsson Comprehensive Cancer Center logo

Jonsson Comprehensive Cancer Center

Status

Completed

Conditions

Breast Cancer

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT01051609
09-09-058

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

27 participants in 1 patient group

Intervention Group
Description:
There is only one arm in this trial. Please see interventions for more detailed descriptions.
Treatment:
Behavioral: Surveys
Other: History and Physical Exam
Procedure: Ultrasound of Hand/Wrist
Other: Blood Collection
Other: Grip Strength Measurement

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems