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

NCT ID: NCT03700983

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-06
• Study Completion Date: 2018-09-30

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Nutri-PEITC jelly

a single serving of 200 g Nutri-PEITC jelly

Group Type: EXPERIMENTAL

Nutri-PEITC jelly

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Nutri-PEITC jelly

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maha Vajiralongkorn Thanyaburi Hospital

UNKNOWN

Sponsor Role: collaborator

Mahidol University

OTHER

Sponsor Role: collaborator

Srinakharinwirot University

OTHER

Sponsor Role: collaborator

Dental Innovation Foundation Under Royal Patronage

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dunyaporn Trachootham, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Other Identifiers

AOF2.2

Identifier Type: -

Identifier Source: org_study_id