Study of IPMN Progression Prevention With Tocotrienol (SIPP-T3)
NCT Number: NCT06519097
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Neoplasm of Pancreas|IPMN, Pancreatic
Interventions: DRUG: Vitamin E Delta Tocotrienol|OTHER: Placebo
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Collaborators: American River Nutrition, LLC|National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 212
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-07-09
Completion Date: 2029-07
Locations: Moffitt Cancer Center, Tampa, Florida, 33612, United States|University of Nebraska Medical Center, Omaha, Nebraska, 68198-6880, United States

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.

Primary Outcome Measures: 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)., Up to 60 Months
Secondary Outcome Measures: 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)., Up to 36 Months|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., Baseline, Month 6, 12, 24 and 36|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., Baseline, Month 6, 12, 24 and 36|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., Baseline, Month 6, 12, 24 and 36