Back to resultsA Pharmacokinetic Study of Nutri-PEITC Jelly in Head and Neck Cancer Survivors
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutri-PEITC jelly
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Cancer
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nutri-PEITC jelly
Arm Description
a single serving of 200 g Nutri-PEITC jelly
Outcomes
Primary Outcome Measures
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.
Time to reach maximum concentration (Tmax)
The duration to reach maximum plasma concentration of PEITC will be calculated.
Secondary Outcome Measures
Area under the curve of plasma concentration of PEITC and time
Graph between plasma concentration and time will be plotted. The area under the curve will be calculated.
Full Information
NCT ID
NCT03700983
First Posted
October 5, 2018
Last Updated
October 6, 2018
Sponsor
Dental Innovation Foundation Under Royal Patronage
Collaborators
Maha Vajiralongkorn Thanyaburi Hospital, Mahidol University, Srinakharinwirot University
1. Study Identification
Unique Protocol Identification Number
NCT03700983
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 6, 2016 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dental Innovation Foundation Under Royal Patronage
Collaborators
Maha Vajiralongkorn Thanyaburi Hospital, Mahidol University, Srinakharinwirot University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutri-PEITC jelly
Arm Type
Experimental
Arm Description
a single serving of 200 g Nutri-PEITC jelly
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutri-PEITC jelly
Intervention Description
an edible, easily to swallow nutritious gel containing a bioactive compound PEITC
Primary Outcome Measure Information:
Title
Maximum plasma concentration (Cmax) of PEITC
Description
Plasma concentration of PEITC during 24 hours after intake of Nutri-jelly will be measured and the highest concentration will be identified.
Time Frame
Day 0 - Day 1
Title
Time to reach maximum concentration (Tmax)
Description
The duration to reach maximum plasma concentration of PEITC will be calculated.
Time Frame
Day 0 - Day 1
Secondary Outcome Measure Information:
Title
Area under the curve of plasma concentration of PEITC and time
Description
Graph between plasma concentration and time will be plotted. The area under the curve will be calculated.
Time Frame
Day 0 - Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dunyaporn Trachootham, DDS, PhD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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A Pharmacokinetic Study of Nutri-PEITC Jelly in Head and Neck Cancer Survivors
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