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Study of IPMN Progression Prevention With Tocotrienol (SIPP-T3)

NCT06519097 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-11-13

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled trial, investigating whether treatment with δ-tocotrienol (a.k.a. Delta-tocotrienol, abbreviated as DT3) will prevent the progression of Intraductal Papillary Mucinous Neoplasm (IPMN) of the pancreas.

Conditions

  • Neoplasm of Pancreas
  • IPMN, Pancreatic

Interventions

DRUG

Vitamin E Delta Tocotrienol

Tocotrienols are natural vitamin E compounds that are known to have a neuroprotective effect at nanomolar concentration and anti-carcinogenic effect at micromolar concentration. 400 mg orally, twice daily

OTHER

Placebo

Placebo contains no active ingredients. 465 mg pure olive oil orally, twice daily

Sponsors & Collaborators

  • American River Nutrition, LLC

    collaborator UNKNOWN

  • National Cancer Institute (NCI)

    collaborator NIH

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Mokenge P Malafa, MD, FACS · Moffitt Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-09
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06519097 on ClinicalTrials.gov