Study of IPMN Progression Prevention With Tocotrienol (SIPP-T3) (NCT06519097) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of IPMN Progression Prevention With Tocotrienol (SIPP-T3)
United States4 participantsStarted 2024-07-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 throug…
What they're measuring
1
IPMN Progression Free Survival (iPFS)
Timeframe: Up to 60 Months
Trial details
NCT IDNCT06519097
SponsorH. Lee Moffitt Cancer Center and Research Institute