RECRUITING

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

Conditions

Pancreatic Cyst Pancreatic Mucinous Cystic Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-22

Study Completion:2027-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06320990

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age ≥ 19 years * Clinically diagnosed pre-invasive pancreatic mucinous cystic neoplasm (MCN), measurable by cross-sectional imaging * Surgical resection of the lesion is not planned due to cyst features, patient factors or patient preference * Females of reproductive potential and males with partners of reproductive potential must agree to employ two methods contraception throughout the study and for up to 3 months following treatment. Non-child-bearing potential is defined as age 45 years or older and no menses for greater than or equal to 12 months or any age with surgical removal of the uterus and/or both ovaries. * Estimated glomerular filtration rate (eGFR) \> 30mL/min/1.73m2 * Willing and able to provide informed consent to and abide by the protocol	* Presence of invasive pancreatic adenocarcinoma or high-grade dysplasia * Presence of a solid component or mural nodule, main pancreatic duct dilation or abrupt caliber change, obstructive jaundice, lymphadenopathy * Current or prior use of tamoxifen or another estrogen antagonist including, but not limited to, clomifene, raloxifene, fulvestrant, anastrazole; subjects who have previously used an estrogen antagonist are eligible provided the last use was at least 5 years prior to enrollment. * Current or planned use of hormonal treatments including estrogen, progesterone, androgens, hormone replacement therapy or other types of hormonal contraceptives including implants and depot injections; levonorgestrel-releasing intrauterine device (IUD) is permitted. * Contraindications to tamoxifen include: * Pregnancy or nursing * Known allergy or hypersensitivity to tamoxifen * Cataracts which affect visual acuity (ie. symptomatic) * Retinopathy which affects visual acuity (ie. symptomatic) * Current warfarin use * History of deep vein thrombosis or pulmonary embolism or other condition which, in the opinion of the investigator, may significantly increase the individual's risk of venous thromboembolism * History of stroke * Known endometrial hyperplasia or personal history of endometrial carcinoma, uterine sarcoma and uterine carcinosarcoma * History of intestinal disease or major gastric surgery likely to alter absorption of tamoxifen or inability to swallow oral medications * Uncontrolled illness including but not limited to ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure, unstable angina or uncontrolled cardiac arrhythmias, or other conditions which might jeopardize or preclude the ability of the patient to take tamoxifen or the safety of follow-up visits, scans and procedures * Elective surgery planned for the study period * Participation in another clinical study with an investigational product during the last 28 days * Any participant, in the opinion of the investigator, who will not be able to tolerate treatment, or the participant is unsuitable to participate in the study and is unlikely to comply with study procedures, restrictions and requirements

Inclusion Criteria

Exclusion Criteria

* Age ≥ 19 years
* Clinically diagnosed pre-invasive pancreatic mucinous cystic neoplasm (MCN), measurable by cross-sectional imaging
* Surgical resection of the lesion is not planned due to cyst features, patient factors or patient preference
* Females of reproductive potential and males with partners of reproductive potential must agree to employ two methods contraception throughout the study and for up to 3 months following treatment. Non-child-bearing potential is defined as age 45 years or older and no menses for greater than or equal to 12 months or any age with surgical removal of the uterus and/or both ovaries.
* Estimated glomerular filtration rate (eGFR) \> 30mL/min/1.73m2
* Willing and able to provide informed consent to and abide by the protocol

* Presence of invasive pancreatic adenocarcinoma or high-grade dysplasia
* Presence of a solid component or mural nodule, main pancreatic duct dilation or abrupt caliber change, obstructive jaundice, lymphadenopathy
* Current or prior use of tamoxifen or another estrogen antagonist including, but not limited to, clomifene, raloxifene, fulvestrant, anastrazole; subjects who have previously used an estrogen antagonist are eligible provided the last use was at least 5 years prior to enrollment.
* Current or planned use of hormonal treatments including estrogen, progesterone, androgens, hormone replacement therapy or other types of hormonal contraceptives including implants and depot injections; levonorgestrel-releasing intrauterine device (IUD) is permitted.
* Contraindications to tamoxifen include:
* Pregnancy or nursing
* Known allergy or hypersensitivity to tamoxifen
* Cataracts which affect visual acuity (ie. symptomatic)
* Retinopathy which affects visual acuity (ie. symptomatic)
* Current warfarin use
* History of deep vein thrombosis or pulmonary embolism or other condition which, in the opinion of the investigator, may significantly increase the individual's risk of venous thromboembolism
* History of stroke
* Known endometrial hyperplasia or personal history of endometrial carcinoma, uterine sarcoma and uterine carcinosarcoma
* History of intestinal disease or major gastric surgery likely to alter absorption of tamoxifen or inability to swallow oral medications
* Uncontrolled illness including but not limited to ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure, unstable angina or uncontrolled cardiac arrhythmias, or other conditions which might jeopardize or preclude the ability of the patient to take tamoxifen or the safety of follow-up visits, scans and procedures
* Elective surgery planned for the study period
* Participation in another clinical study with an investigational product during the last 28 days
* Any participant, in the opinion of the investigator, who will not be able to tolerate treatment, or the participant is unsuitable to participate in the study and is unlikely to comply with study procedures, restrictions and requirements

Contacts and Locations

Study Contact

Mahdi Hassan, MS

CONTACT

402-559-1947

mhassan@unmc.edu

Principal Investigator

Kelsey Klute, MD

PRINCIPAL_INVESTIGATOR

University of Nebraska

Study Locations (Sites)

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Collaborators and Investigators

Sponsor: University of Nebraska

Kelsey Klute, MD, PRINCIPAL_INVESTIGATOR, University of Nebraska

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-22

Study Completion Date2027-05

Study Record Updates

Study Start Date2025-01-22

Study Completion Date2027-05

Terms related to this study

Additional Relevant MeSH Terms

Pancreatic Cyst
Pancreatic Mucinous Cystic Neoplasm