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Examining the Relationships Between Sleep, Fatigue, and Pain in Aromatase Inhibitor-treated Patients

NCT01983995 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 49

Last updated 2016-10-25

No results posted yet for this study

Summary

Aromatase inhibitors are commonly prescribed for treatment of postmenopausal women with breast cancer. These medications can cause side effects in some women, and occasionally they can be quite bothersome. We are doing a study to better understand the side effects of aromatase inhibitors so that we can hopefully treat them better or possibly prevent them. In particular, we are interested in pain and difficulty sleeping. This study is designed to assess the effect of aromatase inhibitors on pain, sleep quality, and fatigue and the interplay of these side effects and their subsequent impact on daily activity. Each participant will fill out a series of questionnaires about pain, sleep quality, and fatigue and will also complete a sleep diary and wear an actigraphy watch for 10 days before starting an aromatase inhibitor and after taking it for 3 months. We hope to learn more about these symptoms so we can better manage medication toxicity in the future.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Norah L Henry, MD, PhD · University of Michigan

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01983995 on ClinicalTrials.gov