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

NCT03034603 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-02-15

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Mahidol University

    collaborator OTHER

  • Srinakharinwirot University

    collaborator OTHER

  • Ministry of Health, Thailand

    collaborator OTHER_GOV

  • Dental Innovation Foundation Under Royal Patronage

    lead OTHER

Principal Investigators

  • Aroonwan Lam-ubol, DDS, PhD · Srinakharinwirot University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2021-02-28
Completion
2023-01-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03034603 on ClinicalTrials.gov