Trial Information
A Prospective Assessment of Loss of Grip Strength by Baseline BMI in Breast Cancer Patients Receiving Adjuvant Third-generation Aromatase Inhibitors and Tamoxifen
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.
Type of Study:
Observational
Study Design:
Time Perspective: Prospective
Outcome Measure:
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.
Outcome Description:
measurements occur at baseline, 3 months, 6 months and 12 months
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Patrick Neven, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospitals Leuven
Authority:
Belgium: Federal Agency for Medicinal Products and Health Products
Study ID:
S51575
NCT ID:
NCT01223833
Start Date:
April 2009
Completion Date:
June 2013
Related Keywords:
- Breast Cancer
- Arthralgia
- breast cancer
- postmenopausal
- aromatase inhibitors
- tamoxifen
- arthralgia
- IGF-I
- BMI
- grip strength
- Arthralgia
- Breast Neoplasms