A Pharmacokinetic Study of Nutri-PEITC Jelly in Head and Neck Cancer Survivors

A Pharmacokinetic Study of PEITC in Nutri-Jelly in Healthy Head and Neck Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Dietary supplement: Nutri-PEITC jelly

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age 20 or above
• Diagnosed with Head and neck cancer
• Completed radiation or chemotherapy since at least 4 weeks ago
• normal physical exam
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
• Life expectancy > 3 months
• Normal kidney function evidenced by serum creatinine, blood urea nitrogen (BUN), no kidney stone, no history of renal dialysis
• Normal liver function evidenced by serum bilirubin, aspartate transaminase (AST), alanine amino transferase (ALT)
• not pregnant or breastfeeding
• no psychiatric symptoms
• normal vital sign and normal blood chemistry including complete blood count CBC)
• provide voluntary inform consent

Exclusion Criteria:

• unable to communicate
• reject to take Nutri-jelly
• unable to refrain from vegetable intake for 3 days prior to the test
• take paracetamol during 2 days prior to the test
• body weight less than 35 kg or higher than 65 kg
• oral infection such as Candidiasis interfering with normal oral intake

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutri-PEITC jelly; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0 - Day 1
Time to reach maximum concentration (Tmax)	The duration to reach maximum plasma concentration of PEITC will be calculated.	Day 0 - Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0 - Day 1

Collaborators and Investigators

• Sponsor: Dental Innovation Foundation Under Royal Patronage
• Collaborators: Mahidol University; Srinakharinwirot University; Maha Vajiralongkorn Thanyaburi Hospital
• Investigators: Principal Investigator: Dunyaporn Trachootham, DDS, PhD, Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: October 6, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 6, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: AOF2.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No