Clinical trial NCT01814397: Pilot Study to Evaluate the Effect of Aromatase Inhibitor Therapy on Pain Threshold in Breast Cancer Patients
Official title: Prospective Pilot Study to Determine the Effect of Aromatase Inhibitor-induced Estrogen Depletion on Evoked Pain Threshold and Psychosocial Factors in Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Pain
Arthralgia
Keywords: Aromatase inhibitor
Pain threshold
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: Damon Runyon Cancer Research Foundation
First posted: 2013-03-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal women with ER positive early stage breast cancer who are starting AI therapy

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Female gender
* 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:

* Average pain \>=8/10 over the past 24 hours
* 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

Primary outcomes:
measure: Mean Pain50 Assessed at Baseline, 3 Months and 6 Months
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Mean Conditioned Pain Modulation Assessed at Baseline, 3 Months, and 6 Months
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
measure: Mean Baseline Patient-reported Symptom Measures for Patients Who Were Persistent and Nonpersistent With Aromatase Inhibitor Therapy During the First 6 Months of Treatment
timeFrame: Baseline patient-reported outcomes measures, 6 month persistence with therapy
measure: Estradiol Concentration Assessments at Baseline and After 3 Months of Aromatase Inhibitor Therapy
timeFrame: Baseline, 3 months
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Norah L Henry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.