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

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ClinicalTrials.gov Identifier: NCT03034603
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : February 1, 2018
Sponsor:
Collaborators:
Mahidol University
Srinakharinwirot University
Ministry of Health, Thailand
Information provided by (Responsible Party):
Dental Innovation Foundation Under Royal Patronage

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : August 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Adverse events [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline, 3 months after receiving intervention ]
    Evaluation of tumor response following RECIST criteria (using CT scan) at 3 months

  2. Changes in Functional status [ Time Frame: Baseline, 1 month and 3 months after receiving intervention ]
    Evaluation of functional status using KPS (Karnofsky Performance Score) score



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034603


Contacts
Contact: Aroonwan Lam-ubol, DDS, PhD 6681-9363145 aroowanlam@gmail.com
Contact: Dunyaporn Trachootham, DDS, PhD dif.dunyaporn@gmail.com

Locations
Thailand
National cancer institute Recruiting
Bankok, Bangkok, Thailand
Contact: Peerawitch Tupwong, MD       peerawitch.t@gmail.com   
Chonburi Cancer Hospital Recruiting
Cholburi, Chonburi, Thailand, 20000
Contact: Thapana Tungcheewinsirikul, MD       tangtangbox@hotmail.com   
Lopburi Cancer Hospital Recruiting
Lopburi, Thailand, 15000
Contact: Jirasak Sukhaboon, MD    6636-621800    fodjiji@gmail.com   
Maharat Nakhon Ratchasima Hospital Recruiting
Nakhon Ratchasima, Thailand, 30000
Contact: Witee Rasiew, MD       socker947@hotmail.com   
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

Responsible Party: Dental Innovation Foundation Under Royal Patronage
ClinicalTrials.gov Identifier: NCT03034603     History of Changes
Other Study ID Numbers: DIF-04
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Phenethyl isothiocyanate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents