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

Breast Cancer Clinical Trial

— LOGRIBMET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223833
• Other study ID #: S51575
• Status: Completed
• Phase: N/A
• First received: October 14, 2010
• Last updated: July 24, 2013
• Start date: April 2009
• Est. completion date: June 2013

Study information

• Verified date: November 2010
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthralgia
• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	measurements occur at baseline, 3 months, 6 months and 12 months	1 year	No
Secondary	IGF-I, GH and IGFBP-3 levels	Serum levels of IGF-I, GH and IGFBP-3 will be measured at baseline, 3, 6 and 12 months after start of treatment.	1 year	No