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

Completed

• Conditions: Breast Cancer; Arthralgia

• Registration Number: NCT01223833
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-10-14
• Study First Submitted QC: 2010-10-18
• Study First Posted: 2010-10-19
• Status Verified: 2010-11
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-07-24
• Last Update Posted: 2013-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 296

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.

Exclusion Criteria

1. Concomitant endocrine therapy for breast cancer.
2. Concomitant intake of sex hormone containing drugs such as hormone replacement therapy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effect of BMI on loss of grip strength measured by a modified sphygmomanometer with baseline, month 3, month 6 and month 12 measurements.	1 year	measurements occur at baseline, 3 months, 6 months and 12 months

Secondary Outcome Measures

Name	Time	Method
IGF-I, GH and IGFBP-3 levels	1 year	Serum levels of IGF-I, GH and IGFBP-3 will be measured at baseline, 3, 6 and 12 months after start of treatment.

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium