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

• Sponsor: Dental Innovation Foundation Under Royal Patronage (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03034603
• Collaborator: Mahidol University (Other), Srinakharinwirot University (Other), Ministry of Health, Thailand (Other)
• Enrollment: 96
• Locations: 5
• Arms: 2
• Anticipated Duration (Months): 100
• Patients Per Site: 19.2
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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 and health-related quality of life. The secondary outcome includes tumor response and functional status.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Neoplasms; Quality of Life; Nutrition Related Cancer	Dietary Supplement: Nutri-jelly with PEITC; Dietary Supplement: Nutri-jelly	N/A

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 and functional status

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: The Safety and Efficacy Test of Nutri-PEITC Jelly in Head and Neck Cancer Patients
• Actual Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Feb 1, 2021
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nutri-jelly with PEITC Continuous intake of Nutri-jelly with PEITC for 200 milligrams 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 Nutri-jelly for 200 milligrams 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.

Outcome Measures

Primary Outcome Measures

1. Adverse events [1 month and 3 months after receiving intervention]

   Evaluation of adverse events by physical examination, blood tests, and interviewing the subjects

2. Changes in Health-related quality of life score compared to baseline [Baseline, 1 month and 3 months after receiving intervention]

   Evaluation of Health-related quality of life by using questionnaire FACT-HN

Secondary Outcome Measures

1. Changes in Tumor response compared to baseline [Baseline, 3 months after receiving intervention]

   Evaluation of tumor response following RECIST criteria (using CT scan) at 3 months

2. Changes in Functional status [Baseline, 1 month and 3 months after receiving intervention]

   Evaluation of functional status using KPS (Karnofsky Performance Score) score

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National cancer institute	Bankok	Bangkok	Thailand
2	Chonburi Cancer Hospital	Cholburi	Chonburi	Thailand	20000
3	Lopburi Cancer Hospital	Lopburi		Thailand	15000
4	Maharat Nakhon Ratchasima Hospital	Nakhon Ratchasima		Thailand	30000
5	Maha Vajiralongkorn Thanyaburi Hospital	Pathum Thani		Thailand	12110

Sponsors and Collaborators

• Dental Innovation Foundation Under Royal Patronage
• Mahidol University
• Srinakharinwirot University
• Ministry of Health, Thailand

Investigators

• Principal Investigator: Aroonwan Lam-ubol, DDS, PhD, Srinakharinwirot University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dental Innovation Foundation Under Royal Patronage
• ClinicalTrials.gov Identifier: NCT03034603
• Other Study ID Numbers: DIF-04
• First Posted: Jan 27, 2017
• Last Update Posted: Mar 25, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Head and Neck Neoplasms

Study Results

No Results Posted as of Mar 25, 2022