Clinical trial NCT03700983: A Pharmacokinetic Study of Nutri-PEITC Jelly in Head and Neck Cancer Survivors
Official title: A Pharmacokinetic Study of PEITC in Nutri-Jelly in Healthy Head and Neck Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: Dental Innovation Foundation Under Royal Patronage
Sponsor class: OTHER
Collaborators: name: Maha Vajiralongkorn Thanyaburi Hospital
name: Mahidol University
name: Srinakharinwirot University
First posted: 2018-10-09
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Head and neck cancer survivors - patients who had been diagnosed with cancer of lip, oral cavity, oropharynx and nasopharynx, received treatment and the oncologists had defined them as "complete remission", and having normal physical exam and blood biochemistry
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of PEITC
timeFrame: Day 0 - Day 1
measure: Time to reach maximum concentration (Tmax)
timeFrame: Day 0 - Day 1
Secondary outcomes:
measure: Area under the curve of plasma concentration of PEITC and time
timeFrame: Day 0 - Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Mahidol University
name: Dunyaporn Trachootham, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: