Tocotrienol for Pancreatic Tumors
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.12345
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.23467
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either DT3 or placebo orally twice daily for 3 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
Active Control
Patients will be given DT3 orally (by mouth) twice daily for 3 years
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
American River Nutrition, LLC
Collaborator
Citations
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 ...
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.
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 ...
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 ...
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.
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 ...
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.
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