NCT03034603

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Dental Innovation Foundation Under Royal Patronage · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Head and Neck Neoplasms
• Quality of Life
• Nutrition Related Cancer

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2014-08-01
• Primary completion: 2021-02-01
• Completion: 2023-01-01
• First posted: 2017-01-27
• Last updated: 2023-02-15

Locations

5 sites across 1 country: Thailand