The Safety and Efficacy Test of Nutri-PEITC Jelly in Head and Neck Cancer Patients

Study Overview
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Brief Summary
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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
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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

Official Title
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The Safety and Efficacy Test of Nutri-PEITC Jelly in Head and Neck Cancer Patients

Conditions
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Head and Neck Neoplasms, Quality of Life, Nutrition Related Cancer

Intervention / Treatment
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* Dietary Supplement: Nutri-jelly with PEITC
* Dietary Supplement: Nutri-jelly


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutri-jelly with PEITC<br>Continuous intake of 200 g Nutri-jelly with 20 mg PEITC per day, five days per week for 3 months. | Dietary Supplement: Nutri-jelly with PEITC<br>* 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.<br>|
| Placebo Comparator: Nutri-jelly<br>Continuous intake of 200 g Nutri-jelly per day, five days per week for 3 months. | Dietary Supplement: Nutri-jelly<br>* Nutri-jelly is an edible nutritious gel for patients with chewing and swallowing difficulties. One milligram of Nutri-jelly contains approximately 1 kcal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Evaluation of adverse events by physical examination, blood tests, and interviewing the subjects | 1 month and 3 months after receiving intervention | 
| Changes in Health-related quality of life score compared to baseline | Evaluation of Health-related quality of life by using questionnaire FACT-HN | Baseline, 1 month and 3 months after receiving intervention | 
| Changes in Tumor response compared to baseline | Evaluation of tumor response following RECIST criteria at 1 month and 3 months | Baseline, 1 month, 3 months after receiving intervention | 
| Progression-free survival time | The length of time during the intervention that the participant lives with stable disease | The time of the intervention until any signs or symptoms of progressive disease be recorded. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum p53 level | Level of both wild type and mutant p53 in serum | 1 month and 3 months after receiving intervention | 
| Serum cytochrome C level | Level of cytochrome C in serum | 1 month and 3 months after receiving intervention | 
| Changes in Functional status | Evaluation of functional status using KPS (Karnofsky Performance Score) score | Baseline, 1 month and 3 months after receiving intervention |