Study on Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Reducing Breast Cancer Risk

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT06195306

This clinical trial is exploring whether taking low dose tamoxifen, with or without omega-3 fatty acids, can help reduce the risk of breast cancer in postmenopausal women who are overweight or obese and at higher risk of developing the disease.

Patient Parameters

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Program Overview

The study aims to find out if low dose tamoxifen, a medication that blocks estrogen in the breast, can lower breast cancer risk in postmenopausal women who are overweight or obese. It also examines if adding omega-3 fatty acids, known for reducing liver fat production, can enhance this effect. Both tamoxifen and omega-3 fatty acids may help in reducing breast cancer risk in these women.

Description

The study has two main parts:

Primary Goals:
- To see how tamoxifen, with or without omega-3 fatty acids, affects a protein called adiponectin in the blood, which is linked to fat and sugar metabolism.
- To compare the effects of tamoxifen alone versus tamoxifen with omega-3 fatty acids on adiponectin levels in overweight and obese postmenopausal women.
Secondary Goals:
- To study how these treatments affect insulin resistance and sensitivity, which are related to how the body processes sugar.
- To examine changes in breast tissue related to estrogen response.
Exploratory Goals:
- To assess changes in blood fats and other proteins related to cancer risk.

Study Design: Participants are divided into two groups:

Group 1: Takes tamoxifen daily for 6 months, with possible extension if needed. They will have mammograms and provide blood samples.
Group 2: Takes tamoxifen and omega-3 fatty acids daily for 6 months, with possible extension if needed. They will also have mammograms and provide blood samples.

After completing the study, participants will have a follow-up visit within 21-35 days.

Eligibility Criteria

Inclusion Criteria

Women aged 45-65 who are postmenopausal.
Must be overweight or obese with a BMI of 25 or higher.
Must have at least two elements of metabolic syndrome, such as high blood pressure or high blood sugar.
Willing to undergo blood tests and breast tissue sampling.
At increased risk of breast cancer due to personal or family history, genetic factors, or other risk assessments.
Must have normal liver function and no active infections like HIV or hepatitis.
Must have at least one breast that has not been treated with radiation or surgery.
Must be able to understand and sign a consent form.

Exclusion Criteria

Women with bilateral breast implants or a history of invasive breast or uterine cancer.
Women currently breastfeeding or with recent diabetes treatment.
Women with a history of blood clots or certain surgeries.
Women planning to start a weight loss program or certain medications.
Women using blood thinners or certain hormone therapies.
Women who have taken tamoxifen or omega-3 supplements recently.
Women with allergies to study medications or with uncontrolled illnesses.

Locations

FACILITY	ZIP	CITY	STATE
University of Kansas Cancer Center	66160	Kansas City	Kansas
Ohio State University Comprehensive Cancer Center	43210	Columbus	Ohio

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