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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03034603
• Other study ID #: DIF-04
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: January 2023

Study information

• Verified date: February 2023
• Source: Dental Innovation Foundation Under Royal Patronage
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: January 2023
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Thailand	National cancer institute	Bankok	Bangkok
Thailand	Chonburi Cancer Hospital	Cholburi	Chonburi
Thailand	Lopburi Cancer Hospital	Lopburi
Thailand	Maharat Nakhon Ratchasima Hospital	Nakhon Ratchasima
Thailand	Maha Vajiralongkorn Thanyaburi Hospital	Pathum Thani

Sponsors (4)

Lead Sponsor	Collaborator
Dental Innovation Foundation Under Royal Patronage	Mahidol University, Ministry of Health, Thailand, Srinakharinwirot University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Evaluation of adverse events by physical examination, blood tests, and interviewing the subjects	1 month and 3 months after receiving intervention
Primary	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
Primary	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
Primary	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	Serum p53 level	Level of both wild type and mutant p53 in serum	1 month and 3 months after receiving intervention
Secondary	Serum cytochrome C level	Level of cytochrome C in serum	1 month and 3 months after receiving intervention
Secondary	Changes in Functional status	Evaluation of functional status using KPS (Karnofsky Performance Score) score	Baseline, 1 month and 3 months after receiving intervention