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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Head and Neck Neoplasms; Nutrition Related Cancer
• Intervention / Treatment: Dietary supplement: Nutri-jelly with PEITC; Dietary supplement: Nutri-jelly

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

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Lopburi, Thailand, 15000
    • Lopburi Cancer Hospital
  • Nakhon Ratchasima, Thailand, 30000
    • Maharat Nakhon Ratchasima Hospital
  • Pathum Thani, Thailand, 12110
    • Maha Vajiralongkorn Thanyaburi Hospital
  • Bangkok
    • Bankok, Bangkok, Thailand
      • National Cancer Institute
  • Chonburi
    • Cholburi, Chonburi, Thailand, 20000
      • Chonburi Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Diagnosis of squamous cell carcinoma in areas of lip, oral cavity, oropharynx and hypopharynx, who receive only palliative care or deny definitive treatment
2. Finished radiotherapy or/and chemotherapy for at least one month
3. Has at least one measurable target lesion
4. Baseline KPS ≥ 40% or ECOG 0-3
5. 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
6. Able to take the intervention (through mouth or NG tube) without aspiration
7. Able to communicate and consent to the study

Exclusion Criteria:

1. Cannot come back for the follow-up visits
2. Receive or had received N-acetylcysteine during the intervention
3. Has systemic diseases that might interfere with the results
4. Chronic kidney disease that requires dialysis
5. Increased risk of aspiration pneumonia
6. Pregnancy or lactation
7. Untreated infectious diseases

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dental Innovation Foundation Under Royal Patronage
• Collaborators: Mahidol University; Ministry of Health, Thailand; Srinakharinwirot University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 25, 2017
• First Posted (Estimate): January 27, 2017

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: DIF-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO