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

NCT03034603 | Completed DMC

• 1 other identifier: DIF-04
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 5

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, 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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Serum p53 level

  1 month and 3 months after receiving intervention

• Serum cytochrome C level

  1 month and 3 months after receiving intervention

• Changes in Functional status

  Baseline, 1 month and 3 months after receiving intervention

Study Arms (2)

Nutri-jelly with PEITC

EXPERIMENTAL

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

PLACEBO COMPARATOR

Continuous intake of 200 g Nutri-jelly per day, five days per week for 3 months.

Dietary Supplement: Nutri-jelly

Interventions

Nutri-jelly with PEITC DIETARY_SUPPLEMENT

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 with PEITC

Nutri-jelly DIETARY_SUPPLEMENT

Nutri-jelly is an edible nutritious gel for patients with chewing and swallowing difficulties. One milligram of Nutri-jelly contains approximately 1 kcal.

Nutri-jelly

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (5)

National cancer institute

Bangkok, Bangkok, Thailand

Location

Chonburi Cancer Hospital

Chon Buri, Changwat Chon Buri, 20000, Thailand

Location

Lopburi Cancer Hospital

Lopburi, 15000, Thailand

Location

Maharat Nakhon Ratchasima Hospital

Nakhon Ratchasima, 30000, Thailand

Location

Maha Vajiralongkorn Thanyaburi Hospital

Pathum Thani, 12110, Thailand

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

phenethyl isothiocyanate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Aroonwan Lam-ubol, DDS, PhD

  Srinakharinwirot University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 27, 2017
• Study Start: August 1, 2014
• Primary Completion: February 1, 2021
• Study Completion: January 1, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (5)