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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: Completed study of Breast Cancer and Obesity, sponsored by University of Michigan Rogel Cancer Center.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Change in BMI between baseline and 12 months of endocrine therapy

Interventions

  • DRUG Tamoxifen
  • DRUG anastrozole, letrozole, exemestane

Study Locations (1)

Michigan

  • University of Michigan Comprehensive Cancer Center - Ann Arbor

Trial Details

FieldValue
Enrollment Target 115 participants
Start Date 2009-09
Est. Completion 2014-08

What the finished NCT01896050 record still lists

NCT01896050 is an observational study that tracks outcomes without assigning an intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower).

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 a single indexed study location in 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.

Similar trials for Breast Cancer

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 NCT01896050's enrollment target sits among peer trials

115 523rd of 1224 higher than 697 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01896050, the US trial registry maintained by the National Library of Medicine. NCT01896050 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.