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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: Completed study of Breast Cancer and Pain, sponsored by University of Michigan Rogel Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Anastrozole
- DRUG letrozole
- DRUG exemestane
Study Locations (1)
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2009-07 |
| Est. Completion | 2013-02 |
What the finished NCT01814397 record still lists
NCT01814397 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01814397's enrollment target sits among peer trials
50 789th of 1224 higher than 410 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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