RecruitingPhase 1NCT06320990

Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection

A Pilot Study of Chemoprevention With Tamoxifen in Patients With Pre-Invasive Pancreas Mucinous Cystic Neoplasms Who Will Not Undergo Immediate Resection

Sponsor

University of Nebraska

Enrollment

15 participants

Start Date

Jan 22, 2025

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cyst Pancreatic Mucinous Cystic Neoplasm

Summary

Pancreatic mucinous cystic neoplasm (MCN) is a precursor to invasive pancreatic adenocarcinoma which occurs almost exclusively in females in their 5th-7th decade. Currently the only option for MCN treatment and prevention of invasive pancreatic ductal adenocarcinoma (PDA) is oncologic resection. The clinical features of pancreatic MCN support the influence of sex hormones in the pathogenesis of the disease. Anti-hormonal therapy may therefore constitute an effective approach to treatment. Preliminary analyses from preclinical studies suggest that tamoxifen inhibits the spread and normal life cycle in MCN epithelial cells and fibroblasts. Investigators hypothesize that in humans, treatment with tamoxifen will lead to cyst regression or stabilization and may spare or delay the need for resection. Up to 15 participants not undergoing immediate resection will be enrolled and take tamoxifen orally for up to 24 weeks. The study will assess the feasibility of tamoxifen as a treatment for pancreatic MCN.

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether tamoxifen — a drug commonly used in breast cancer — can slow the growth of pre-cancerous cysts in the pancreas called mucinous cystic neoplasms (MCNs) in patients who are being monitored rather than having immediate surgery. **You may be eligible if...** - You are 19 years or older - You have been diagnosed with a pancreatic mucinous cystic neoplasm (a pre-cancerous fluid-filled cyst) that is visible on imaging - Your doctor has decided not to remove it surgically at this time - You have adequate kidney function - You are willing to use two forms of contraception if you are of reproductive potential **You may NOT be eligible if...** - Your cyst shows signs of already being invasive cancer - You have had prior treatment with tamoxifen - You have a history of blood clots or stroke - You are pregnant or planning to become pregnant - You have significant liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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