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


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Arthralgia

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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

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