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

Dental Innovation Foundation Under Royal Patronage

Status: Completed

Conditions: Head and Neck Cancer

Treatments: Dietary Supplement: Nutri-PEITC jelly

Study type: Interventional

Funder types: Other

Identifiers

NCT03700983

AOF2.2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Nutri-PEITC jelly

Experimental group

Description:

a single serving of 200 g Nutri-PEITC jelly

Treatment:

Dietary Supplement: Nutri-PEITC jelly