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Pilot Study to Evaluate the Effect of Aromatase Inhibitor Therapy on Pain Threshold in Breast Cancer Patients

NCT01814397 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-02-07

Study results available
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Summary

Postmenopausal women who have hormone receptor positive breast cancer are typically treated with aromatase inhibitor medications, which substantially decrease the amount of estrogen produced by their bodies. These medications are fairly well tolerated, but can cause aches and pains which can be quite severe in some cases.

People experience pain differently. Estrogen appears to play a role in how we experience pain. Therefore, decreasing estrogen levels may lead to more pain in some women than others. The goal of this study is to evaluate perception of pain in women with breast cancer, and to determine if differences in pain perception lead to more aches and pains in some women treated with aromatase inhibitors.

In this study, we plan to enroll 55 women with breast cancer who are starting treatment with an aromatase inhibitor. Participants will undergo testing to evaluate their perception of pain, and will also complete a set of questionnaires. Testing will be conducted before starting aromatase inhibitor therapy, as well as after 3 and 6 months of therapy. We will investigate whether pre-existing differences in pain perception lead to different amounts of pain during aromatase inhibitor therapy.

Conditions

Interventions

DRUG

Anastrozole

1 mg orally daily

DRUG

exemestane

25 mg orally daily

DRUG

letrozole

2.5 mg orally daily

Sponsors & Collaborators

  • Damon Runyon Cancer Research Foundation

    collaborator OTHER

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Norah L Henry, MD, PhD · University of Michigan Rogel Cancer Center

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-07-31
Completion
2013-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT01814397 on ClinicalTrials.gov