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NCT01896050 · ClinicalTrials.gov registry record
Loss of Grip Strength, BMI, and Adjuvant Endocrine Therapy Breast Cancer
A clinical trial of Breast Cancer and Obesity, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- 115
- Enrollment target
- 1
- Study location
NCT01896050 is a study of Breast Cancer and Obesity that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 115 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01896050, a study of Breast Cancer and Obesity, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- 115 participants
- Enrollment target
- 1
- Study location
Study Summary
Early stage hormone receptor positive breast cancer is typically treated with adjuvant endocrine therapy in order to decrease risk of breast cancer recurrence and to improve overall survival from the disease. Typical agents used for treatment include tamoxifen and the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is increasingly common because it is associated with fewer long-term serious toxicities compared to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of patients, which can influence adherence to therapy and can lead to treatment discontinuation in a minority of cases. The mechanism underlying development of this toxicity remains unclear, and predictors of who will develop these symptoms remain undefined. Initial reports suggest that grip strength decreases during aromatase inhibitor therapy, and that body-mass index may influence development of this symptom. Therefore, this longitudinal study has been developed to determine change in grip strength over time in women treated with aromatase inhibitors and tamoxifen, as well as to identify potential associations between change in grip strength and BMI. Patient self-reported symptoms will also be collected. A total of 115 women with early stage breast cancer who are initiating therapy with either an aromatase inhibitor or tamoxifen will be enrolled.
Conditions Studied
Interventions
- DRUG Tamoxifen
- DRUG anastrozole, letrozole, exemestane
Study Locations (1)
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2009-09 |
| Est. Completion | 2014-08 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01896050
The ClinicalTrials.gov registry entry for NCT01896050 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 115 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 (96% 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 2 interventions - of which Tamoxifen is the first listed.
NCT01896050 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT01896050 about?
NCT01896050 is a clinical study titled "Loss of Grip Strength, BMI, and Adjuvant Endocrine Therapy Breast Cancer". Early stage hormone receptor positive breast cancer is typically treated with adjuvant endocrine therapy in order to decrease risk of breast cancer recurrence and to improve overall survival from the disease. Typical agents used for treatment include tamoxifen and the aromatase inhibitors. In postme...
What is the current status of trial NCT01896050?
This trial is currently completed. The enrollment target is 115 participants. The study started on 2009-09. Estimated completion is 2014-08.
What conditions does trial NCT01896050 study?
This clinical trial studies the following conditions: Breast Cancer, Obesity, Arthralgia.
What interventions are being tested in trial NCT01896050?
The interventions under investigation include: Tamoxifen (DRUG), anastrozole, letrozole, exemestane (DRUG).
Who is sponsoring clinical trial NCT01896050?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01896050 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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Related
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