Actively Recruiting
Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection
Led by University of Nebraska · Updated on 2026-05-14
15
Participants Needed
1
Research Sites
222 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Chemoprevention With Tamoxifen in Pre-Invasive Pancreas Mucinous Cystic Neoplasms Not Undergoing Immediate Resection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63; 19 years
- Clinically diagnosed pre-invasive pancreatic mucinous cystic neoplasm (MCN), measurable by cross-sectional imaging
- No planned surgical removal of the cyst due to cyst features, patient factors, or preference
- Females of reproductive potential and males with partners of reproductive potential must use two contraception methods during the study and for 3 months after treatment; non-child-bearing potential defined as age 45 or older with no menses for 63; 12 months or surgical removal of uterus and/or ovaries
- Estimated glomerular filtration rate (eGFR) greater than 30 mL/min/1.73m2
- Willing and able to provide informed consent and follow the study protocol
You will not qualify if you...
- Presence of invasive pancreatic adenocarcinoma or high-grade dysplasia
- Presence of solid component or mural nodule, main pancreatic duct dilation or abrupt change, obstructive jaundice, lymphadenopathy
- Current or prior use of tamoxifen or other estrogen antagonists within 5 years
- Current or planned use of hormonal treatments including estrogen, progesterone, androgens, hormone replacement therapy, or hormonal contraceptives except levonorgestrel-releasing IUD
- Pregnancy or nursing
- Known allergy or sensitivity to tamoxifen
- Symptomatic cataracts or retinopathy affecting vision
- Current use of warfarin
- History of deep vein thrombosis, pulmonary embolism, or high risk of blood clots
- History of stroke
- Known endometrial hyperplasia or personal history of endometrial carcinoma, uterine sarcoma, or uterine carcinosarcoma
- History of intestinal disease or major stomach surgery affecting tamoxifen absorption or inability to swallow pills
- Uncontrolled illness including active infections, serious heart problems, or other conditions that affect safety or treatment tolerance
- Planned elective surgery during the study
- Participation in another clinical trial with investigational treatment within 28 days
- Any condition making the participant unsuitable or unlikely to follow study procedures or treatment requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
Research Team
M
Mahdi Hassan, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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