Effect of Aromatase Inhibitors on Blood Sugar Levels in Breast Cancer Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates how aromatase inhibitor therapy affects glucose metabolism in post-menopausal women with hormone receptor positive breast cancer. It compares glucose homeostasis indices among women undergoing this treatment to those on tamoxifen and healthy post-menopausal women. Participants will undergo blood sample collection, glucose testing, body composition measurement via DEXA scan, and complete a questionnaire while their medical records are reviewed. The study aims to provide insights into the diabetes risk associated with hormone-directed breast cancer therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Post-menopausal women with hormone receptor positive breast cancer, ductal carcinoma in situ (DCIS), or with other high risk breast conditions. Post-menopause will be defined as women who experience 12 months of amenorrhea or have undergone bilateral salpingo-oophorectomy.

  * 25 women who are planning to start or are within 6 months of starting treatment with aromatase inhibitors, after consultation in breast clinic and cancer center.
  * 25 women who will be starting Tamoxifen (comparative group)
  * 25 healthy post menopausal women will also be recruited.

Exclusion Criteria:

* Established diagnosis of diabetes
* Therapy with medications that could affect glucose metabolism
* Screening fasting glucose ≥ 126 mg/dl, and/or HbA1c ≥ 6.5%
* History of upper GI surgery that alters gastric emptying or causing malabsorption e.g., bariatric surgery, fundoplication

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Kalpana Muthusamy, MBBS, MD — Mayo Clinic in Rochester
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.