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

NCT ID: NCT06519097

Last Updated: 2025-11-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-09
• Study Completion Date: 2026-09-30

Brief 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

Keywords

Papillary Mucinous Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vitamin E Delta-tocotrienol (DT3)

Patients will be given DT3 orally (by mouth) twice daily for 3 years

Group Type: EXPERIMENTAL

Vitamin E Delta Tocotrienol

Intervention Type: DRUG

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

Placebo

Patients will be given a placebo (a substance that looks like the study drug, but contains not active ingredients) orally (by mouth) twice daily for 3 years

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo contains no active ingredients.

465 mg pure olive oil orally, twice daily

Interventions

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

Intervention Type: DRUG

Placebo

Placebo contains no active ingredients.

465 mg pure olive oil orally, twice daily

Intervention Type: OTHER

Other Intervention Names

DT3

Eligibility Criteria

Inclusion Criteria

• Men and women, age ≥18 years.
• Evidence of IPMN as confirmed by MRI/Magnetic Resonance Cholangiopancreatography (MRCP) or pathology with biomarker results from Endoscopic Ultrasound-Guided Fine Needle Aspiration (EUS/FNA).
• IPMN must be suitable for active surveillance as defined by the international Kyoto guidelines and the European guidelines. Patients eligible for our study will have IPMN with no "high-risk stigmata" and no "worrisome features" and also have a neoplasm size of 1-<3 cm.
• Able to complete all of the periodic activities of active surveillance as defined by the international Kyoto guidelines (2024) (Appendix VII) and the European guidelines (clinic visit evaluation, blood work, MRI/MRCP, and EUS).
• Eastern Cooperative Oncology Group = 0-2.
• Participants must have adequate organ and marrow function.
• Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should undergo a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification (see Appendix VI). To be eligible for this trial, participants should be class I-II.
• Agrees to avoid dietary sources of increased DT3 and abstain from consuming non-study DT3 supplements, any other dietary supplements, herbal remedies and over the counter (OTC) medicines (except use of aspirin for which data will be collected in Oncore) beginning 3 days prior to start of study drug and throughout duration of the study. DT3 levels are extremely low in normal foods. Therefore, no specific foods need to be avoided. All supportive care medications, e.g., antiemetics, antidiarrheals growth factors etc. may be used at the discretion of the treating physician and according to institutional guidelines.
• Ability to understand and the willingness to sign a written informed consent document.
• Participants must agree to refrain from getting pregnant, breastfeeding or fathering a child for the duration of the study. Female participants of child-bearing potential and male participants with a female partner of child-bearing potential must agree to use an effective birth control method, as specified in the informed consent form, throughout the study and for 6 months following the last dose of DT3. For purposes of this study, child-bearing potential is defined as a premenopausal woman without permanent sterilization who has the potential to become pregnant by being exposed to sexual intercourse with a non-sterilized male partner. Examples of birth control methods include:

• Oral birth control pills
• Birth control patch
• Implanted (injectable contraceptive hormones or mechanical products such as intrauterine device)
• Barrier methods (such as: diaphragm, condoms, or spermicides)
• Tubal ligation or vasectomy
• Abstinence (no sexual intercourse)

Exclusion Criteria

• Evidence of Pancreatic Ductal Adenocarcinoma (PDAO or other cancers (excluding non-melanoma skin cancer) or metastatic disease.
• Concurrent systemic chemotherapy for any other cancer.
• Use of increased dietary sources of DT3, non-study DT3 supplements, any other dietary supplements, herbal remedies and OTC medicines (except use of aspirin for which data will be collected in Oncore) which may affect the study outcome unless the participant is willing to discontinue taking them 3 days prior to start of study drug DT3 and for the duration of the study. DT3 levels are extremely low in normal foods. Therefore, no specific foods need to be avoided.
• Participants may not be receiving any other investigational agents.
• History of allergic reaction attributed to vitamins.
• Patient is lactating, pregnant or planning to become pregnant during the trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American River Nutrition, LLC

UNKNOWN

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mokenge P Malafa, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

Moffitt Cancer Center

Tampa, Florida, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

R01CA263575

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MCC-21791

Identifier Type: -

Identifier Source: org_study_id