Skip to main content
OpenTrials
Completed

NCT Number: NCT03700983

A Pharmacokinetic Study of Nutri-PEITC Jelly in 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutri-PEITC jelly

Dietary Supplement

an edible, easily to swallow nutritious gel containing a bioactive compound PEITC

Primary outcomes

  1. Maximum plasma concentration (Cmax) of PEITC

    Time frame: Day 0 - Day 1

    Plasma concentration of PEITC during 24 hours after intake of Nutri-jelly will be measured and the highest concentration will be identified.

  2. Time to reach maximum concentration (Tmax)

    Time frame: Day 0 - Day 1

    The duration to reach maximum plasma concentration of PEITC will be calculated.

Secondary outcomes

  1. Area under the curve of plasma concentration of PEITC and time

    Time frame: Day 0 - Day 1

    Graph between plasma concentration and time will be plotted. The area under the curve will be calculated.

Sponsors and collaborators

Lead sponsor

Dental Innovation Foundation Under Royal Patronage

Other

Collaborators

  • Maha Vajiralongkorn Thanyaburi Hospital
  • Mahidol University
  • Srinakharinwirot University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 9, 2018
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.