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

NCT03700983 | Completed DMC

• 1 other identifier: AOF2.2
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• Time to reach maximum concentration (Tmax)

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

  Day 0 - Day 1

Secondary Outcomes (1)

• Area under the curve of plasma concentration of PEITC and time

  Day 0 - Day 1

Study Arms (1)

Nutri-PEITC jelly

EXPERIMENTAL

a single serving of 200 g Nutri-PEITC jelly

Dietary Supplement: Nutri-PEITC jelly

Interventions

Nutri-PEITC jelly DIETARY_SUPPLEMENT

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

Nutri-PEITC jelly

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dental Innovation Foundation Under Royal Patronage: lead
• Maha Vajiralongkorn Thanyaburi Hospital: collaborator
• Mahidol University: collaborator
• Srinakharinwirot University: collaborator

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Dunyaporn Trachootham, DDS, PhD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 9, 2018
• Study Start: August 6, 2016
• Primary Completion: July 1, 2018
• Study Completion: September 30, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share