Back to resultsThe Safety and Efficacy Test of Nutri-PEITC Jelly in Head and Neck Cancer Patients
Primary Purpose
Head and Neck Neoplasms, Quality of Life, Nutrition Related Cancer
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Nutri-jelly with PEITC
Nutri-jelly
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of squamous cell carcinoma in areas of lip, oral cavity, oropharynx and hypopharynx, who receive only palliative care or deny definitive treatment
- Finished radiotherapy or/and chemotherapy for at least one month
- Has at least one measurable target lesion
- Baseline KPS ≥ 40% or ECOG 0-3
- Blood tests are in acceptable ranges (neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L; Hb ≥ 9.0 g/dL), renal function (clearance creatinine using the CKD-EPI formula (Chronic Kidney Disease Epidemiology group) ≥50 mL/min) and hepatic function (SGOT , SGPT, serum bilirubin ≤ 1.5 of upper limits of normal
- Able to take the intervention (through mouth or NG tube) without aspiration
- Able to communicate and consent to the study
Exclusion Criteria:
- Cannot come back for the follow-up visits
- Receive or had received N-acetylcysteine during the intervention
- Has systemic diseases that might interfere with the results
- Chronic kidney disease that requires dialysis
- Increased risk of aspiration pneumonia
- Pregnancy or lactation
- Untreated infectious diseases
Sites / Locations
- National cancer institute
- Chonburi Cancer Hospital
- Lopburi Cancer Hospital
- Maharat Nakhon Ratchasima Hospital
- Maha Vajiralongkorn Thanyaburi Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nutri-jelly with PEITC
Nutri-jelly
Arm Description
Continuous intake of 200 g Nutri-jelly with 20 mg PEITC per day, five days per week for 3 months.
Continuous intake of 200 g Nutri-jelly per day, five days per week for 3 months.
Outcomes
Primary Outcome Measures
Adverse events
Evaluation of adverse events by physical examination, blood tests, and interviewing the subjects
Changes in Health-related quality of life score compared to baseline
Evaluation of Health-related quality of life by using questionnaire FACT-HN
Changes in Tumor response compared to baseline
Evaluation of tumor response following RECIST criteria at 1 month and 3 months
Progression-free survival time
The length of time during the intervention that the participant lives with stable disease
Secondary Outcome Measures
Serum p53 level
Level of both wild type and mutant p53 in serum
Serum cytochrome C level
Level of cytochrome C in serum
Changes in Functional status
Evaluation of functional status using KPS (Karnofsky Performance Score) score
Full Information
NCT ID
NCT03034603
First Posted
January 25, 2017
Last Updated
February 13, 2023
Sponsor
Dental Innovation Foundation Under Royal Patronage
Collaborators
Mahidol University, Srinakharinwirot University, Ministry of Health, Thailand
1. Study Identification
Unique Protocol Identification Number
NCT03034603
Brief Title
The Safety and Efficacy Test of Nutri-PEITC Jelly in Head and Neck Cancer Patients
Official Title
The Safety and Efficacy Test of Nutri-PEITC Jelly in Head and Neck Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
February 2021 (Actual)
Study Completion Date
January 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dental Innovation Foundation Under Royal Patronage
Collaborators
Mahidol University, Srinakharinwirot University, Ministry of Health, Thailand
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This triple-blinded randomized placebo control trial aims to investigate the safety and efficacy of Nutri-PEITC jelly, a functional food, in head and neck cancer patients. The primary outcome measure includes adverse events, health-related quality of life, tumor response and progression-free survival. The secondary outcome includes serum p53 and cytochrome C levels and functional status.
Detailed Description
Previously, Nutri-jelly, a novel edible nutritious gel for patients with chewing and swallowing difficulties, was shown to be effective in improving the quality of life of head and neck cancer patients. Recently, Nutri-PEITC jelly is recently developed by addition of Phenethyl Isothiocyanate (PEITC), a phytochemical compound with chemopreventive action in animal bearing oral cancer. It intends to be a functional food for cancer survivor. The dose of PEITC in Nutri-jelly was based on safe and effective dose determined in animal studies. Furthermore, Nutri-PEITC jelly was proven safe in healthy volunteers who daily consumes for a consecutive month with no serious adverse events. The purpose of this study is to determine safety and efficacy of Nutri-jelly with PEITC in head and neck cancer patients.
independent variable: continuous Nutri -jelly with PEITC intake dependent variable (outcome): adverse effects, health-related quality of life score, tumor response, progression-free survival, serum p53 and cytochrome C levels and functional status
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms, Quality of Life, Nutrition Related Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nutri-jelly with PEITC
Arm Type
Experimental
Arm Description
Continuous intake of 200 g Nutri-jelly with 20 mg PEITC per day, five days per week for 3 months.
Arm Title
Nutri-jelly
Arm Type
Placebo Comparator
Arm Description
Continuous intake of 200 g Nutri-jelly per day, five days per week for 3 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutri-jelly with PEITC
Intervention Description
Nutri-jelly with PEITC resulted from an addition of tested amount of PEITC, which was shown in animal model to delay cancer growth, into Nutri-jelly.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutri-jelly
Intervention Description
Nutri-jelly is an edible nutritious gel for patients with chewing and swallowing difficulties. One milligram of Nutri-jelly contains approximately 1 kcal.
Primary Outcome Measure Information:
Title
Adverse events
Description
Evaluation of adverse events by physical examination, blood tests, and interviewing the subjects
Time Frame
1 month and 3 months after receiving intervention
Title
Changes in Health-related quality of life score compared to baseline
Description
Evaluation of Health-related quality of life by using questionnaire FACT-HN
Time Frame
Baseline, 1 month and 3 months after receiving intervention
Title
Changes in Tumor response compared to baseline
Description
Evaluation of tumor response following RECIST criteria at 1 month and 3 months
Time Frame
Baseline, 1 month, 3 months after receiving intervention
Title
Progression-free survival time
Description
The length of time during the intervention that the participant lives with stable disease
Time Frame
The time of the intervention until any signs or symptoms of progressive disease be recorded.
Secondary Outcome Measure Information:
Title
Serum p53 level
Description
Level of both wild type and mutant p53 in serum
Time Frame
1 month and 3 months after receiving intervention
Title
Serum cytochrome C level
Description
Level of cytochrome C in serum
Time Frame
1 month and 3 months after receiving intervention
Title
Changes in Functional status
Description
Evaluation of functional status using KPS (Karnofsky Performance Score) score
Time Frame
Baseline, 1 month and 3 months after receiving intervention
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of squamous cell carcinoma in areas of lip, oral cavity, oropharynx and hypopharynx, who receive only palliative care or deny definitive treatment
Finished radiotherapy or/and chemotherapy for at least one month
Has at least one measurable target lesion
Baseline KPS ≥ 40% or ECOG 0-3
Blood tests are in acceptable ranges (neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L; Hb ≥ 9.0 g/dL), renal function (clearance creatinine using the CKD-EPI formula (Chronic Kidney Disease Epidemiology group) ≥50 mL/min) and hepatic function (SGOT , SGPT, serum bilirubin ≤ 1.5 of upper limits of normal
Able to take the intervention (through mouth or NG tube) without aspiration
Able to communicate and consent to the study
Exclusion Criteria:
Cannot come back for the follow-up visits
Receive or had received N-acetylcysteine during the intervention
Has systemic diseases that might interfere with the results
Chronic kidney disease that requires dialysis
Increased risk of aspiration pneumonia
Pregnancy or lactation
Untreated infectious diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aroonwan Lam-ubol, DDS, PhD
Organizational Affiliation
Srinakharinwirot University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National cancer institute
City
Bankok
State/Province
Bangkok
Country
Thailand
Facility Name
Chonburi Cancer Hospital
City
Cholburi
State/Province
Chonburi
ZIP/Postal Code
20000
Country
Thailand
Facility Name
Lopburi Cancer Hospital
City
Lopburi
ZIP/Postal Code
15000
Country
Thailand
Facility Name
Maharat Nakhon Ratchasima Hospital
City
Nakhon Ratchasima
ZIP/Postal Code
30000
Country
Thailand
Facility Name
Maha Vajiralongkorn Thanyaburi Hospital
City
Pathum Thani
ZIP/Postal Code
12110
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
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The Safety and Efficacy Test of Nutri-PEITC Jelly in Head and Neck Cancer Patients
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