A Prospective Assessment of Loss of Grip Strength by Baseline BMI in Breast Cancer Patients Receiving Adjuvant Aromatase Inhibitors and Tamoxifen

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

296 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2013-06-30

Brief Summary

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The Logribmet study is a prospective study that evaluate grip strength changes in both hands of postmenopausal women with breast cancer receiving treatment with tamoxifen or an aromatase inhibitor. Patients included in the study will undergo a grip strength measurement and receive a rheumatological questionnaire prior to the start of treatment, then at 3 and 6 months and at year 1 into therapy. Furthermore, BMI will be measured to assess if BMI is a predictor for the decrease in grip strength.

IGF-I, GH and IGFBP-3 serum levels will also be measured at all time points.

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Detailed Description

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Conditions

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Breast Cancer Arthralgia

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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tamoxifen

100 postmenopausal women with early breast cancer treated with tamoxifen in the adjuvant setting

No interventions assigned to this group

aromatase inhibitors

200 postmenopausal women with early breast cancer treated with an aromatase inhibitor in the adjuvant setting

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Patients with early breast cancer who are scheduled to receive endocrine therapy with tamoxifen or any of the third-generation aromatase inhibitors, anastrozole, letrozole or exemestane.
2. No major rheumatological disorders such as severe rheumatoid arthritis.
3. Patients must have provided informed consent for participation in this study.