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

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT06320990
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Pancreatic Cyst
  • Pancreatic Mucinous Cystic Neoplasm

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tamoxifen 20mg — DRUG
    Tamoxifen is a nonsteroidal antiestrogen for oral administration.

Study Details

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.

Key Dates

Start date
Jan 22, 2025
Status verified
Jun 2025
Primary completion
Nov 30, 2028
Completion
May 31, 2029

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Tamoxifen
    Tamoxifen 20mg by mouth daily for up to 6 months

Primary Outcome Measure

Feasibility, by adherence rate [ Time Frame: 6 months (approximately 180 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical CenterOmahaNebraska68198
Mahdi Hassan, MS
[email protected]
Kelsey Klute, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Omaha, NE

By research site
University of Nebraska Medical Center· Omaha, NE

Related Studies