Tocotrienol for Pancreatic Tumors

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if delta-tocotrienol (a form of Vitamin E) can prevent the progression of pancreatic growths known as Intraductal Papillary Mucinous Neoplasms (IPMN). Participants will take delta-tocotrienol or a placebo (a harmless pill) twice daily for three years. The trial is suitable for individuals with IPMN who are under observation, have growths between 1 and less than 3 cm, and do not exhibit serious risk signs. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that Delta Tocotrienol is likely to be safe for humans?

Research has shown that delta-tocotrienol, a type of vitamin E, is generally safe for people. In past studies, participants took up to 3200 mg without major problems. This treatment specifically targets pancreatic cancer cells, potentially causing less harm to healthy cells. While it is well-tolerated, some side effects may occur. Prospective participants should discuss all possible risks with their doctor before joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pancreatic tumors?

Unlike the standard treatments for pancreatic tumors, which typically involve chemotherapy and targeted therapies, Delta Tocotrienol (DT3) is derived from Vitamin E and offers a novel approach. Researchers are excited about DT3 because it has antioxidant properties that may help reduce tumor growth and improve patient outcomes. Additionally, its oral administration makes it more convenient for patients compared to some existing therapies, which require intravenous delivery. This unique mechanism and ease of use make DT3 a promising option in the fight against pancreatic tumors.

What evidence suggests that Delta Tocotrienol might be an effective treatment for pancreatic tumors?

Research has shown that delta-tocotrienol, a natural form of vitamin E, can slow cancer growth and stop tumors from spreading. It effectively kills pancreatic cancer cells while leaving normal cells unharmed. In this trial, one group of participants will receive delta-tocotrienol, while another group will receive a placebo. Previous clinical trials found that patients taking delta-tocotrienol did not experience negative side effects, even at high doses. This suggests that delta-tocotrienol might help prevent pancreatic tumors from growing or spreading. ^{2 3 4 6 7}

Who Is on the Research Team?

Mokenge P Malafa, MD, FACS

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. wjgnet.com wjgnet.com/1948-5204/full/v15/i6/943.htm

Vitamin E in the management of pancreatic cancer A clinical trial recorded no adverse effects in pancreatic cancer patients treated with 3200 mg/d (53.33 mg/kg) of δ-TT[53]. More conclusive ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5458229/

δ-Tocotrienol, a natural form of vitamin E, inhibits ... We have demonstrated that δ-tocotrienol, a natural form of vitamin E (VEDT), is bioactive against cancer, delays progression, and prevents metastases.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00985777

Study Details | NCT00985777 | Vitamin E δ-Tocotrienol ... Vitamin E Delta-tocotrienol is being investigated for the prevention and treatment of pancreatic tumors. The usefulness of the Vitamin E Delta-tocotrienol in ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-06413

Delta-Tocotrienol for Preventing Progression to Cancer in ... Delta-tocotrienol has been shown to be effective in killing human pancreatic tumor cells. Delta-tocotrienol may be effective in preventing pancreatic tumors ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352396415302073

A Phase I Safety, Pharmacokinetic, and Pharmacodynamic ... Vitamin E δ-tocotrienol selectively kills pancreatic tumor cells when compared with normal cells at 400, 600, and 800 mg/day.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4703733/

A Phase I Safety, Pharmacokinetic, and Pharmacodynamic ... Vitamin E δ-tocotrienol is safe in patients up to 3200 mg. •. Vitamin E δ-tocotrienol selectively kills pancreatic tumor cells when compared with normal cells ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0753332223018760

Delta-tocotrienol disrupts PD-L1 glycosylation and ... We demonstrated for the first time that delta-tocotrienol (δ-T3) not any of the other forms of vitamin E was able to disrupt PD-L1 glycosylation.