Actively Recruiting
Chemoprevention With Tamoxifen in Patients With 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
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying pancreatic mucinous cystic neoplasm (MCN), a condition that can lead to invasive pancreatic adenocarcinoma, mostly affecting women aged 40 to 70. Since current treatment involves surgery, this trial explores whether tamoxifen, an anti-hormonal drug, can help reduce or stabilize cysts and potentially delay the need for surgery. This pilot study aims to assess the feasibility of using tamoxifen for MCN treatment and to gather information to guide future trials. Participants will take tamoxifen 20 mg orally once daily for up to 24 weeks. This open-label study enrolls up to 15 people with pancreatic MCN who are not scheduled for immediate surgery. The study focuses on evaluating how well participants adhere to and tolerate the daily tamoxifen treatment over six months. During the study, participants will undergo magnetic resonance imaging (MRI) to monitor cyst changes and will be regularly assessed for treatment adherence and retention. The main outcomes measured include adherence to tamoxifen over six months and the cyst response over one year. Safety and participant retention will also be closely monitored, with the entire observation period lasting up to 12 months.
CONDITIONS
Brief 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 19 years or older
- Clinically diagnosed pre-invasive pancreatic mucinous cystic neoplasm measurable by 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 agree to use two contraception methods during the study and for 3 months after treatment; non-child-bearing potential defined by age or surgical history
- Estimated kidney function (eGFR) above 30 mL/min/1.73m2
- Willing and able to give 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, mural nodule, main pancreatic duct dilation or abrupt change, obstructive jaundice, or lymphadenopathy
- Current or recent use of tamoxifen or other estrogen antagonists within past 5 years
- Current or planned use of hormonal treatments including estrogen, progesterone, androgens, hormone replacement therapy, or hormonal contraceptives except levonorgestrel-releasing IUD
- Contraindications to tamoxifen including pregnancy, nursing, allergy to tamoxifen, symptomatic cataracts or retinopathy, current warfarin use, history of blood clots or stroke, or certain uterine diseases
- History of intestinal disease or major stomach surgery affecting tamoxifen absorption or inability to swallow pills
- Uncontrolled illness such as active infection requiring IV antibiotics, heart failure, unstable angina, uncontrolled arrhythmias, or other conditions risking treatment safety or follow-up
- Planned elective surgery during the study period
- Participation in another investigational study within 28 days
- Investigator judgment deeming participant unable to tolerate treatment or unlikely to comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants take tamoxifen 20mg by mouth daily as chemoprevention for pancreatic mucinous cystic neoplasms.
Regular visits during treatment to monitor adherence and safety
Duration - Up to 12 months after treatment
Participants are monitored for up to 12 months to assess cyst response by imaging and long-term outcomes.
Periodic imaging visits as scheduled
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
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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