Prospective Pilot Study to Determine the Effect of Aromatase Inhibitor-induced Estrogen Depletion on Evoked Pain Threshold and Psychosocial Factors in Breast Cancer Patients
Overview
- Phase
- Not Applicable
- Intervention
- Anastrozole
- Conditions
- Breast Cancer
- Sponsor
- University of Michigan Rogel Cancer Center
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Mean Pain50 Assessed at Baseline, 3 Months and 6 Months
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Arms & Interventions
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.
Intervention: Anastrozole
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.
Intervention: exemestane
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.
Intervention: letrozole
Outcomes
Primary Outcomes
Mean Pain50 Assessed at Baseline, 3 Months and 6 Months
Time Frame: Baseline, 3 months, 6 months
Patients rated the intensity of each pressure sensation using a 0 to 100 numerical rating scale (0 = no pain, 100 = worst pain imaginable). Pain50 was defined as the amount of applied pressure in kilograms per square centimeter that evoked a pain intensity rating of 50 out of 100. Pain50 was assessed at baseline, 3 months, and 6 months. Change in Pain50 with estrogen depletion was determined.
Secondary Outcomes
- Mean Conditioned Pain Modulation Assessed at Baseline, 3 Months, and 6 Months(Baseline, 3 months, 6 months)