Completed

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

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What is being collected

Drug Data

+ drug Data

+ drug Data

Collected from today forward - Prospective
DrugDNA Samples
Who is being recruted

Breast Diseases+10

+ Joint Diseases

+ Musculoskeletal Diseases

Over 21 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2009
See protocol details

Summary

Principal SponsorUniversity of Michigan Rogel Cancer Center
Last updated: February 7, 2024
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2009

Actual date on which the first participant was enrolled.

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.

NCT01814397
Principal SponsorUniversity of Michigan Rogel Cancer Center
Last updated: February 7, 2024
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesJoint DiseasesMusculoskeletal DiseasesNeoplasmsNeoplasms by SiteNeurologic ManifestationsSigns and SymptomsSkin DiseasesPathological Conditions, Signs and SymptomsSkin and Connective Tissue DiseasesBreast NeoplasmsPainArthralgia

Criteria

5 inclusion criteria required to participate
Female gender

Performance status 0-2

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

Show More Criteria

4 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Michigan Comprehensive Cancer Center

Ann Arbor, United StatesOpen University of Michigan Comprehensive Cancer Center in Google Maps
CompletedOne Study Center