Trial Title:
Study of IPMN Progression Prevention With Tocotrienol (SIPP-T3)
NCT ID:
NCT06519097
Condition:
Neoplasm of Pancreas
IPMN, Pancreatic
Conditions: Official terms:
Neoplasms
Pancreatic Neoplasms
Pancreatic Intraductal Neoplasms
Vitamin E
Tocopherols
Tocotrienols
Conditions: Keywords:
Papillary Mucinous Neoplasm
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Care Provider)
Masking description:
All eligible patients will be allocated randomly to one of 2 groups, the DT3 group and
the Placebo group. Surgeons, medical oncologists, advanced practice professionals (APPs)
(nurse practitioners and physician assistants) at the follow-up outpatient clinics, and
patients will be blinded to the allocation. Patients in the DT3 group shall receive oral
DT3 400 mg twice per day, and those in the placebo group shall receive oral placebo twice
per day.
Intervention:
Intervention type:
Drug
Intervention name:
Vitamin E Delta Tocotrienol
Description:
Tocotrienols are natural vitamin E compounds that are known to have a neuroprotective
effect at nanomolar concentration and anti-carcinogenic effect at micromolar
concentration.
400 mg orally, twice daily
Arm group label:
Vitamin E Delta-tocotrienol (DT3)
Other name:
DT3
Intervention type:
Other
Intervention name:
Placebo
Description:
Placebo contains no active ingredients.
465 mg pure olive oil orally, twice daily
Arm group label:
Placebo
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Men and women, age ≥18 years.
- 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).
- Eastern Cooperative Oncology Group = 0-2.
- Participants must have adequate organ and marrow function.
- Participants with known history or current symptoms of cardiac disease, or history
of treatment with cardiotoxic agents, should undergo a clinical risk assessment of
cardiac function using the New York Heart Association Functional Classification (see
Appendix VI). To be eligible for this trial, participants should be class I-II.
- Agrees to avoid dietary sources of increased DT3 and abstain from consuming
non-study DT3 supplements, any other dietary supplements, herbal remedies and over
the counter (OTC) medicines (except use of aspirin for which data will be collected
in Oncore) beginning 3 days prior to start of study drug and throughout duration of
the study. DT3 levels are extremely low in normal foods. Therefore, no specific
foods need to be avoided. All supportive care medications, e.g., antiemetics,
antidiarrheals growth factors etc. may be used at the discretion of the treating
physician and according to institutional guidelines.
- Ability to understand and the willingness to sign a written informed consent
document.
- Participants must agree to refrain from getting pregnant, breastfeeding or fathering
a child for the duration of the study. Female participants of child-bearing
potential and male participants with a female partner of child-bearing potential
must agree to use an effective birth control method, as specified in the informed
consent form, throughout the study and for 6 months following the last dose of DT3.
For purposes of this study, child-bearing potential is defined as a premenopausal
woman without permanent sterilization who has the potential to become pregnant by
being exposed to sexual intercourse with a non-sterilized male partner. Examples of
birth control methods include:
- Oral birth control pills
- Birth control patch
- Implanted (injectable contraceptive hormones or mechanical products such as
intrauterine device)
- Barrier methods (such as: diaphragm, condoms, or spermicides)
- Tubal ligation or vasectomy
- Abstinence (no sexual intercourse)
Exclusion Criteria:
- Evidence of Pancreatic Ductal Adenocarcinoma (PDAO or other cancers (excluding
non-melanoma skin cancer) or metastatic disease.
- Concurrent systemic chemotherapy for any other cancer.
- Use of increased dietary sources of DT3, non-study DT3 supplements, any other
dietary supplements, herbal remedies and OTC medicines (except use of aspirin for
which data will be collected in Oncore) which may affect the study outcome unless
the participant is willing to discontinue taking them 3 days prior to start of study
drug DT3 and for the duration of the study. DT3 levels are extremely low in normal
foods. Therefore, no specific foods need to be avoided.
- Participants may not be receiving any other investigational agents.
- History of allergic reaction attributed to vitamins.
- Patient is lactating, pregnant or planning to become pregnant during the trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alicia Chin
Phone:
813-745-2261
Email:
Alicia.Chin@moffitt.org
Investigator:
Last name:
Mokenge P Malafa, MD, FACS
Email:
Principal Investigator
Investigator:
Last name:
Tiago Biachi De Castria, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jason Denbo, MD
Email:
Sub-Investigator
Investigator:
Last name:
Pamela Hodul, MD
Email:
Sub-Investigator
Investigator:
Last name:
Dae Won Kim, MD
Email:
Sub-Investigator
Investigator:
Last name:
Richard Kim, MD
Email:
Sub-Investigator
Investigator:
Last name:
Shaffer Mok, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jose Pimiento, MD
Email:
Sub-Investigator
Investigator:
Last name:
Andrew Sinnamon, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jonathan Strosberg, MD
Email:
Sub-Investigator
Facility:
Name:
University of Nebraska Medical Center
Address:
City:
Omaha
Zip:
68198-6880
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Quan P Ly, MD, FACS
Phone:
402-559-8941
Email:
QLy@unmc.edu
Investigator:
Last name:
Quan P Ly, MD, FACS
Email:
Principal Investigator
Investigator:
Last name:
Surinder K Batra, PhD
Email:
Sub-Investigator
Start date:
July 9, 2024
Completion date:
July 2029
Lead sponsor:
Agency:
H. Lee Moffitt Cancer Center and Research Institute
Agency class:
Other
Collaborator:
Agency:
American River Nutrition, LLC
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
H. Lee Moffitt Cancer Center and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06519097
http://www.moffitt.org/clinical-trials-research/clinical-trials/
