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CompletedNCT01223833LOGRIBMETUpdated Jul 25, 2013

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

An observational study in Breast Cancer and Arthralgia, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-25.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
296
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer
  • Arthralgia

Keywords

  • breast cancer
  • postmenopausal
  • aromatase inhibitors
  • tamoxifen
  • arthralgia
  • IGF-I
  • BMI
  • grip strength
03

In context

Breast Neoplasms

12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's enrollment of 296 is above the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 959 studies on the registry; 263 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Concomitant endocrine therapy for breast cancer.
  2. Concomitant intake of sex hormone containing drugs such as hormone replacement therapy.
05

Study design

Time perspective
Prospective
Enrollment
296 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year

Secondary outcomes

  1. 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.

    Time frame: 1 year

07

Study locations

1 site
  • University Hospitals Leuven
    Leuven, 3000, Belgium
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2009, a primary completion of Jun 2013 and a completion of Jun 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 14, 2010
First posted
Oct 19, 2010
Start
Apr 2009
Primary completionActual
Jun 2013
CompletionActual
Jun 2013
Last update
Jul 25, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01223833
Responsible party
Sponsor
First posted
Oct 19, 2010
Start date
Apr 2009
Primary completion
Jun 2013
Completion
Jun 2013
Last update
Jul 25, 2013

Study contacts

Patrick Neven, MD PhD
principal investigator · Universitaire Ziekenhuizen KU Leuven

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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