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Neoplasm of PancreasPhase 2NCT06519097

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

A Phase 2 study testing Vitamin E Delta Tocotrienol in people with Neoplasm of Pancreas and IPMN, Pancreatic, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasm of Pancreas, IPMN, Pancreatic
What is being tested?
Vitamin E Delta Tocotrienol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4 participants
Where
2 sitesUnited States
Study dates
9 Jul 2024to Sep 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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)

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-6880

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Randomized, Placebo-Controlled Trial of Tocotrienol in the Prevention of Pancreatic Intraductal Papillary Mucinous Neoplasm Progression

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.

Being tested
Vitamin E Delta Tocotrienol, Placebo
Keywords
Papillary Mucinous Neoplasm
Medical subject headings
Pancreatic Neoplasms, Pancreatic Intraductal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin E Delta TocotrienolDrug

    Also called DT3

    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

  • PlaceboOther

    Placebo contains no active ingredients.

    465 mg pure olive oil orally, twice daily

Study groups in NCT06519097
Study groupRoleWhat they receive
Vitamin E Delta-tocotrienol (DT3)ExperimentalPatients will be given DT3 orally (by mouth) twice daily for 3 years
Receives: Drug: Vitamin E Delta Tocotrienol
PlaceboActive comparatorPatients 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
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. IPMN Progression Free Survival (iPFS)

    IPMN progression free survival (iPFS) defined as duration from date of randomization to date of event (IPMN progression), pursuant to the international Kyoto guidelines and the European guidelines.

    IPMN will be considered as having progressed if any one or more of the following features occur:

    (i) increase in size of > 1 mm; (ii) development of any worrisome feature (growth rate ≥ 5 mm/ 2 years, main pancreatic duct dilatation from 5-9 mm, acute pancreatitis caused by IPMN, enhancing mural nodule < 5 mm, increased serum CA 19-9 ≥ 37 U/ml, and cyst diameter ≥ 3 cm); or development of any high-risk stigmata (positive cytology for malignancy, solid mass, tumor related jaundice, enhancing mural nodule ≥ 5 mm, and main pancreatic duct dilatation ≥ 10 mm).

    Measured: Up to 60 Months

Secondary outcomes (4)

  1. Time to Surgical Intervention (TSI)

    The time to surgical intervention (TSI), defined as duration from date of randomization to date of event (Surgical Intervention for IPMN).

    Measured: Up to 36 Months

  2. Bioavailability and Biodistribution

    The difference of DT3 and metabolite levels will be measured in IPMN cyst fluid, plasma, and urine before and after treatment in the DT3 arm.

    The analytes will be quantified by comparing the peak heights with those of the serum, urine, and cyst standards.

    Measured: Baseline, Month 6, 12, 24 and 36

  3. Acceptability of DT3 Treatment

    Quality of life (QoL) and functional health and well-being from the patient's point of view (SF-36v2) will be evaluated before the start of treatment and at each follow-up.

    DT3 acceptability will be analyzed as a change of SF36 score before and after treatment to assess quality of life.

    Overall compliance of 80% adherence to study agent intake will be required during the 3-year intervention.

    Measured: Baseline, Month 6, 12, 24 and 36

  4. Adherence of DT3 Treatment

    To determine the adherence of DT3 treatment, participants will be provided with the Study Agent Intake and Symptom Log that the subject will complete daily.

    Overall compliance of 80% adherence to study agent intake will be required during the 3-year intervention.

    Measured: Baseline, Month 6, 12, 24 and 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2024
  2. Study start9 Jul 2024
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06519097
Sponsor's protocol ID
MCC-21791
Other IDs
R01CA263575
Status last verified
Nov 2025
First submitted
19 Jul 2024
Last updated
13 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vitamin E Delta Tocotrienol in people with Neoplasm of Pancreas and IPMN, Pancreatic, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IPMN Progression Free Survival (iPFS) (time frame: Up to 60 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06519097.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.

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