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出境医 / 临床实验 / A Pharmacokinetic Study of Nutri-PEITC Jelly in Head and Neck Cancer Survivors

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

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Dietary Supplement: Nutri-PEITC jelly Not Applicable

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pharmacokinetic Study of PEITC in Nutri-Jelly in Healthy Head and Neck Cancer Survivors
Actual Study Start Date : August 6, 2016
Actual Primary Completion Date : July 1, 2018
Actual Study Completion Date : September 30, 2018
Arms and Interventions
Arm Intervention/treatment
Experimental: Nutri-PEITC jelly
a single serving of 200 g Nutri-PEITC jelly
 Dietary Supplement: Nutri-PEITC jelly
an edible, easily to swallow nutritious gel containing a bioactive compound PEITC
Outcome Measures
Primary Outcome Measures :
  1. Maximum plasma concentration (Cmax) of PEITC [ Time Frame: Day 0 - Day 1 ]
    Plasma concentration of PEITC during 24 hours after intake of Nutri-jelly will be measured and the highest concentration will be identified.

  2. Time to reach maximum concentration (Tmax) [ Time Frame: Day 0 - Day 1 ]
    The duration to reach maximum plasma concentration of PEITC will be calculated.


Secondary Outcome Measures :
  1. Area under the curve of plasma concentration of PEITC and time [ Time Frame: Day 0 - Day 1 ]
    Graph between plasma concentration and time will be plotted. The area under the curve will be calculated.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Sponsors and Collaborators
Dental Innovation Foundation Under Royal Patronage
Maha Vajiralongkorn Thanyaburi Hospital
Mahidol University
Srinakharinwirot University
Investigators
Layout table for investigator information
Principal Investigator: Dunyaporn Trachootham, DDS, PhD Mahidol University
Tracking Information
First Submitted Date  ICMJE October 5, 2018
First Posted Date  ICMJE October 9, 2018
Last Update Posted Date October 9, 2018
Actual Study Start Date  ICMJE August 6, 2016
Actual Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2018)
  • Maximum plasma concentration (Cmax) of PEITC [ Time Frame: Day 0 - Day 1 ]
    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) [ Time Frame: Day 0 - Day 1 ]
    The duration to reach maximum plasma concentration of PEITC will be calculated.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2018) 		Area under the curve of plasma concentration of PEITC and time [ Time Frame: Day 0 - Day 1 ]
Graph between plasma concentration and time will be plotted. The area under the curve will be calculated.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pharmacokinetic Study of Nutri-PEITC Jelly in Head and Neck Cancer Survivors
Official Title  ICMJE A Pharmacokinetic Study of PEITC in Nutri-Jelly in Healthy Head and Neck Cancer Survivors
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
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
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE Dietary Supplement: Nutri-PEITC jelly
an edible, easily to swallow nutritious gel containing a bioactive compound PEITC
Study Arms  ICMJE Experimental: Nutri-PEITC jelly
a single serving of 200 g Nutri-PEITC jelly
Intervention: Dietary Supplement: Nutri-PEITC jelly
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2018) 		12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 30, 2018
Actual Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03700983
Other Study ID Numbers  ICMJE AOF2.2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dental Innovation Foundation Under Royal Patronage
Study Sponsor  ICMJE Dental Innovation Foundation Under Royal Patronage
Collaborators  ICMJE
  • Maha Vajiralongkorn Thanyaburi Hospital
  • Mahidol University
  • Srinakharinwirot University
Investigators  ICMJE
Principal Investigator: Dunyaporn Trachootham, DDS, PhD Mahidol University
PRS Account Dental Innovation Foundation Under Royal Patronage
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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