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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Arthralgia

• Study Type: Observational
• Enrollment (Actual): 296

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospitals Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Postmenopausal early breast cancer patients scheduled to start adjuvant hormonal therapy with any of the third generation aromatase inhibitors or tamoxifen in University Hospitals Leuven.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
tamoxifen; 100 postmenopausal women with early breast cancer treated with tamoxifen in the adjuvant setting
aromatase inhibitors; 200 postmenopausal women with early breast cancer treated with an aromatase inhibitor in the adjuvant setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Patrick Neven, MD PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: October 14, 2010
• First Submitted That Met QC Criteria: October 18, 2010
• First Posted (Estimate): October 19, 2010

Study Record Updates

• Last Update Posted (Estimate): July 25, 2013
• Last Update Submitted That Met QC Criteria: July 24, 2013
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: aromatase inhibitors; breast cancer; tamoxifen; postmenopausal; BMI; IGF-I; grip strength; arthralgia
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Breast Diseases; Joint Diseases; Musculoskeletal Diseases; Breast Neoplasms; Arthralgia
• Other Study ID Numbers: S51575