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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03700983
• Other study ID #: AOF2.2
• Status: Completed
• Phase: N/A
• Start date: August 6, 2016
• Est. completion date: September 30, 2018

Study information

• Verified date: October 2018
• Source: Dental Innovation Foundation Under Royal Patronage
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 30, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Dietary Supplement:
• Nutri-PEITC jelly
an edible, easily to swallow nutritious gel containing a bioactive compound PEITC

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Dental Innovation Foundation Under Royal Patronage	Faculty of Dentistry, Srinakarinwirot University, Maha Vajiralongkorn Thanyaburi Hospital, Mahidol University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Time to reach maximum concentration (Tmax)	The duration to reach maximum plasma concentration of PEITC will be calculated.	Day 0 - Day 1
Secondary	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