CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Anastrozole +2 moredrug
Likely dose
Anastrozole 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01814397
NCT01814397N/ACompleted

Prospective Pilot Study to Determine the Effect of Aromatase Inhibitor-induced Estrogen Depletion on Evoked Pain Threshold and Psychosocial Factors in Breast Cancer Patients

University of Michigan Rogel Cancer Center·observational·Posted Mar 19, 2013·Updated Feb 7, 2024

In Brief

An observational study evaluating Anastrozole, exemestane, and 1 other intervention for Breast Cancer and 2 related conditions. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 19, 2013
Enrollment StartJul 1, 2009
Primary CompletionJul 1, 2012
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 13.3 years ago

Interventions

Anastrozoledrug

1 mg orally daily

exemestanedrug

25 mg orally daily

letrozoledrug

2.5 mg orally daily