Tocotrienol for Pancreatic Tumors

Recruiting at 1 trial location

Overseen By Alicia Chin

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Chemotherapy, Investigational agents

Disqualifiers: Pancreatic cancer, Other cancers, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 36 months

4 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

You may need to stop taking any dietary supplements, herbal remedies, and over-the-counter medicines (except aspirin) starting 3 days before the study and throughout its duration. However, supportive care medications like anti-nausea or anti-diarrhea drugs can be used if your doctor approves.

What data supports the effectiveness of the drug Delta Tocotrienol for pancreatic tumors?

Research shows that Delta Tocotrienol, a form of vitamin E, can enhance the effectiveness of gemcitabine, a common chemotherapy drug, in treating pancreatic cancer. It works by inhibiting NF-κB, a protein that helps cancer cells survive, and has been shown to significantly reduce tumor growth in both lab and animal studies. ^{1 2 3 4 5}

Is delta-tocotrienol safe for humans?

In a Phase I clinical trial, delta-tocotrienol was found to be safe and well-tolerated in patients with pancreatic ductal neoplasia, with no significant toxicity observed in preclinical studies on mice. ^{1 2 3 5 6}

How is the drug delta-tocotrienol unique in treating pancreatic tumors?

Delta-tocotrienol, a form of vitamin E, is unique because it enhances the effectiveness of gemcitabine, a standard chemotherapy drug, by inhibiting NF-κB (a protein that helps cancer cells survive) in pancreatic cancer cells. It is also notable for its ability to concentrate in the pancreas and show significant anti-tumor activity without causing toxicity. ^{1 2 3 5 6}

Research Team

Mokenge P Malafa, MD, FACS

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

This trial is for individuals with a condition called IPMN, which can lead to pancreatic cancer. Participants should not have received prior treatment for this condition and must be in stable health otherwise.

Inclusion Criteria

* 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).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either DT3 or placebo orally twice daily for 3 years

36 months

Visits at Baseline, Month 6, 12, 24, and 36

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Delta Tocotrienol

Trial Overview The study is testing if taking a form of Vitamin E known as Delta-tocotrienol (DT3) can stop IPMN from getting worse. It's a blind test, so neither the doctors nor patients know who gets DT3 or a placebo.

Participant Groups

Group I: Vitamin E Delta-tocotrienol (DT3) Experimental Treatment 1 Intervention

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

Group II: Placebo Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

American River Nutrition, LLC

Collaborator

Trials

1

Recruited

4+

References

1. United States pubmed.ncbi.nlm.nih.gov

Vitamin E δ-tocotrienol augments the antitumor activity of gemcitabine and suppresses constitutive NF-κB activation in pancreatic cancer. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

A Phase I Safety, Pharmacokinetic, and Pharmacodynamic Presurgical Trial of Vitamin E δ-tocotrienol in Patients with Pancreatic Ductal Neoplasia. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Vitamin E δ-tocotrienol prolongs survival in the LSL-KrasG12D/+;LSL-Trp53R172H/+;Pdx-1-Cre (KPC) transgenic mouse model of pancreatic cancer. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

{Gamma}-tocotrienol inhibits pancreatic tumors and sensitizes them to gemcitabine treatment by modulating the inflammatory microenvironment. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Vitamin E delta-tocotrienol levels in tumor and pancreatic tissue of mice after oral administration. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Prolonged survival and delayed progression of pancreatic intraepithelial neoplasia in LSL-KrasG12D/+;Pdx-1-Cre mice by vitamin E δ-tocotrienol. [2022]