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OpenTrials
Completed

NCT Number: NCT01896050

Loss of Grip Strength, BMI, and Adjuvant Endocrine Therapy Breast Cancer

Early stage hormone receptor positive breast cancer is typically treated with adjuvant endocrine therapy in order to decrease risk of breast cancer recurrence and to improve overall survival from the disease. Typical agents used for treatment include tamoxifen and the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is increasingly common because it is associated with fewer long-term serious toxicities compared to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of patients, which can influence adherence to therapy and can lead to treatment discontinuation in a minority of cases. The mechanism underlying development of this toxicity remains unclear, and predictors of who will develop these symptoms remain undefined. Initial reports suggest that grip strength decreases during aromatase inhibitor therapy, and that body-mass index may influence development of this symptom. Therefore, this longitudinal study has been developed to determine change in grip strength over time in women treated with aromatase inhibitors and tamoxifen, as well as to identify potential associations between change in grip strength and BMI. Patient self-reported symptoms will also be collected. A total of 115 women with early stage breast cancer who are initiating therapy with either an aromatase inhibitor or tamoxifen will be enrolled.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stage 0-III breast cancer who are scheduled to receive endocrine therapy with tamoxifen or an aromatase inhibitor
  • All prior surgery and chemotherapy should be complete
  • Age 18 and above and postmenopausal

Exclusion criteria

  • Major rheumatologic disorders
  • Concomitant sex hormone containing drugs or Leutinizing Hormone Releasing Hormone agonist therapy
  • For those subjects initiating treatment with an aromatase inhibitor, prior tamoxifen within 4 weeks of enrollment
  • For those subjects initiating treatment with tamoxifen, prior aromatase inhibitor within 4 weeks of enrollment

Treatment and study plan

anastrozole, letrozole, exemestane

Drug

Patients were treated with one of the listed anti-hormonal medications for up to one year

Other names: Arimidex, Femara, Aromasin

Tamoxifen

Drug

Patients were treated with tamoxifen for up to one year

Other names: Novaldex

Primary outcomes

  1. Effect of Change in Body Mass Index on Change in Grip Strength With Aromatase Inhibitor Therapy

    Time frame: baseline and 12 months

    Change in BMI between baseline and 12 months of endocrine therapy

Secondary outcomes

  1. Effect of Medication on Change in Grip Strength

    Time frame: baseline and 12 months

    Effect of either aromatase inhibitor or tamoxifen therapy on change in grip strength between baseline and 12 months

  2. Association Between Baseline Body Mass Index and Discontinuation of Aromatase Inhibitor Therapy Within the First 12 Months

    Time frame: baseline and 12 months

    Associations between baseline BMI and whether or not aromatase inhibitor-treated patients discontinued treatment by 12 months. In the original statistical analysis plan, it was only intended to examine the association with aromatase inhibitor-treated patients, and not tamoxifen-treated patients. The numbers below reflect the number of patients in each group who discontinued initial endocrine therapy within the first 12 months of treatment

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Official study title

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

Acronym: LOGRIBMET

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jul 11, 2013
Registry last updated
Jun 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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