An interventional study of Nutri-PEITC jelly in Head and Neck Cancer, sponsored by Dental Innovation Foundation Under Royal Patronage. Completed. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-09.
Sponsored by Dental Innovation Foundation Under Royal Patronage · Not applicable, Interventional, and Supportive care
This research aims to evaluate the absorption and elimination profile of a bioactive compound PEITC in the matrix of Nutri-jelly - a novel edible nutritious gel. Thus, the investigators conducted a pharmacokinetic study in 12 head and neck cancer survivors. After consumed a serving of Nutri-jelly containing 20 mg PEITC, plasma levels of PEITC at 0, 1, 2, 3, 4, 6, 8, 12 and 24 hours were specifically measured by ammonia derivatization and analyzed by liquid chromatography-mass spectrometry (LC-MS/MS). Non-compartmental pharmacokinetic analysis was performed.
β-phenylethyl isothiocyanate (PEITC) is a phytochemical found in cruciferous vegetables with anti-cancer properties in vitro and in vivo. However, its pharmacokinetic profile in cancer survivors were unknown. A pharmacokinetic study was conducted in head and neck cancer survivors to evaluate the absorption and elimination profile of PEITC in the matrix of Nutri-jelly - a novel edible nutritious gel. Twelve head and neck cancer survivors consumed a serving of Nutri-jelly containing 20 mg PEITC. Plasma levels of PEITC at 0, 1, 2, 3, 4, 6, 8, 12 and 24 hours were specifically measured by ammonia derivatization and analyzed by LC-MS/MS. Non-compartmental pharmacokinetic analysis was performed. Pharmacokinetic parameters including Cmax, Tmax, half-life, clearance were analyzed.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 12 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Dental Innovation Foundation Under Royal Patronage is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
a single serving of 200 g Nutri-PEITC jelly
Dietary Supplement: Nutri-PEITC jelly
an edible, easily to swallow nutritious gel containing a bioactive compound PEITC
Maximum plasma concentration (Cmax) of PEITC
Plasma concentration of PEITC during 24 hours after intake of Nutri-jelly will be measured and the highest concentration will be identified.
Time frame: Day 0 - Day 1
Time to reach maximum concentration (Tmax)
The duration to reach maximum plasma concentration of PEITC will be calculated.
Time frame: Day 0 - Day 1
Area under the curve of plasma concentration of PEITC and time
Graph between plasma concentration and time will be plotted. The area under the curve will be calculated.
Time frame: Day 0 - Day 1
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Dental Innovation Foundation Under Royal Patronage