A Pharmacokinetic Study of Nutri-PEITC Jelly in Head and... | NCT03700983

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

NCT03700983

Sponsor

Dental Innovation Foundation Under Royal Patronage

Status

Completed

Last Update Posted

Oct 9, 2018Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Head and Neck Cancer

Interventions

Nutri-PEITC jelly

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 6, 2016Actual

Primary Completion Date

Jul 1, 2018Actual

Completion Date

Sep 30, 2018Actual

First Submitted Date

Oct 5, 2018

First Submission Date that Met QC Criteria

Oct 6, 2018

First Posted Date

Oct 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2018

Last Update Posted Date

Oct 9, 2018Actual

Name	Class
Maha Vajiralongkorn Thanyaburi Hospital	UNKNOWN
Mahidol University	OTHER
Srinakharinwirot University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nutri-PEITC jelly	Experimental	a single serving of 200 g Nutri-PEITC jelly	Dietary Supplement: Nutri-PEITC jelly

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nutri-PEITC jelly	Dietary Supplement	an edible, easily to swallow nutritious gel containing a bioactive compound PEITC	Nutri-PEITC jelly

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.	Day 0 - Day 1

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Dunyaporn Trachootham, DDS, PhD	Mahidol University	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D006258	Head and Neck Neoplasms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

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