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Vitamin E
Tocotrienol for Pancreatic Tumors
Phase 2
Recruiting
Led By Mokenge P Malafa, MD, FACS
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 6, 12, 24 and 36
Summary
This trial is testing if a medication called δ-tocotrienol can stop the growth of a certain type of pancreatic tumor called Intraductal Papillary Mucinous Neoplasm (IP
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with vitamin E supplements may include fatigue, headache, blurred vision, rash, bruising or bleeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, month 6, 12, 24 and 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 6, 12, 24 and 36
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
IPMN Progression Free Survival (iPFS)
Secondary study objectives
Acceptability of DT3 Treatment
Adherence of DT3 Treatment
Bioavailability and Biodistribution
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Vitamin E Delta-tocotrienol (DT3)Experimental Treatment1 Intervention
Patients will be given DT3 orally (by mouth) twice daily for 3 years
Group II: PlaceboActive Control1 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
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
564 Previous Clinical Trials
144,588 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,951 Previous Clinical Trials
41,111,583 Total Patients Enrolled
American River Nutrition, LLCUNKNOWN
Mokenge P Malafa, MD, FACSPrincipal InvestigatorMoffitt Cancer Center