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

University of Michigan Rogel Cancer Center

Status: Completed

Conditions: Breast Cancer; Arthralgia; Pain

Treatments: Drug: Anastrozole; Drug: exemestane; Drug: letrozole

Study type: Observational

Funder types: Other

Identifiers

NCT01814397

UMCC 2008.101

HUM00026034 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Women starting AI therapy

Description:

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.

Treatment:

Drug: letrozole

Drug: exemestane

Drug: Anastrozole