Pilot Study to Evaluate the Effect of Aromatase Inhibitor Therapy on Pain Threshold in Breast Cancer Patients
NCT ID: NCT01814397
Last Updated: 2024-02-07
Study Results
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View full resultsBasic Information
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COMPLETED
50 participants
OBSERVATIONAL
2009-07-31
2013-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Women starting AI therapy
There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
Anastrozole
1 mg orally daily
exemestane
25 mg orally daily
letrozole
2.5 mg orally daily
Interventions
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Anastrozole
1 mg orally daily
exemestane
25 mg orally daily
letrozole
2.5 mg orally daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Postmenopausal, age 21 or greater
* Stage 0-III estrogen receptor and/or progesterone receptor positive breast cancer who will be receiving a standard dose of letrozole, anastrozole, or exemestane
* Performance status 0-2
* Willing to sign the consent form
Exclusion Criteria
* Peripheral sensory neuropathy grade 2 or higher
* Personal history of schizophrenia, or suicidal ideation or attempt within the past 2 years
* Thumbnail abnormalities on either hand that are likely to alter pain perception during testing
21 Years
FEMALE
No
Sponsors
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Damon Runyon Cancer Research Foundation
OTHER
University of Michigan Rogel Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Norah L Henry, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center
Locations
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University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Countries
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References
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Henry NL, Conlon A, Kidwell KM, Griffith K, Smerage JB, Schott AF, Hayes DF, Williams DA, Clauw DJ, Harte SE. Effect of estrogen depletion on pain sensitivity in aromatase inhibitor-treated women with early-stage breast cancer. J Pain. 2014 May;15(5):468-75. doi: 10.1016/j.jpain.2014.01.487. Epub 2014 Jan 22.
Other Identifiers
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HUM00026034
Identifier Type: OTHER
Identifier Source: secondary_id
UMCC 2008.101
Identifier Type: -
Identifier Source: org_study_id
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