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NCT01814397 · ClinicalTrials.gov registry record

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

A clinical trial of Breast Cancer and Pain, sponsored by University of Michigan Rogel Cancer Center.

Completed
Registry status
50
Enrollment target
1
Study location

NCT01814397 is a study of Breast Cancer and Pain that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 50 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01814397, a study of Breast Cancer and Pain, has completed, sponsored by University of Michigan Rogel Cancer Center.

COMPLETED
Registry status
50 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • DRUG Anastrozole
  • DRUG letrozole
  • DRUG exemestane

Study Locations (1)

Michigan

  • University of Michigan Comprehensive Cancer Center - Ann Arbor

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2009-07
Est. Completion 2013-02

What the Registry Record Tells You About NCT01814397

The ClinicalTrials.gov registry entry for NCT01814397 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Anastrozole is the first listed.

NCT01814397 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.

Frequently Asked Questions

What is clinical trial NCT01814397 about?

NCT01814397 is a clinical study titled "Pilot Study to Evaluate the Effect of Aromatase Inhibitor Therapy on Pain Threshold in Breast Cancer Patients". 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 quit...

What is the current status of trial NCT01814397?

This trial is currently completed. The enrollment target is 50 participants. The study started on 2009-07. Estimated completion is 2013-02.

What conditions does trial NCT01814397 study?

This clinical trial studies the following conditions: Breast Cancer, Pain, Arthralgia.

What interventions are being tested in trial NCT01814397?

The interventions under investigation include: Anastrozole (DRUG), letrozole (DRUG), exemestane (DRUG).

Who is sponsoring clinical trial NCT01814397?

This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01814397 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.