Effect of Aromatase Inhibitors on Blood Sugar Levels in Breast Cancer Patients
Impact of Aromatase Inhibitor Therapy on Glucose Homeostasis and Diabetes Risk
This study is testing how a breast cancer treatment called aromatase inhibitors affects blood sugar levels in post-menopausal women compared to those on a different treatment and healthy women.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 66 (estimated) |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06557057 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include post-menopausal women with hormone receptor positive breast cancer who are starting or have recently started aromatase inhibitor therapy.
Not a fit: Patients with an established diagnosis of diabetes or those on medications affecting glucose metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify diabetes risk factors in breast cancer patients undergoing aromatase inhibitor therapy, leading to better management strategies.
How similar studies have performed: Other studies have explored the effects of cancer therapies on metabolic health, but this specific focus on aromatase inhibitors and glucose homeostasis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rochester, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.