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
|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|
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|
|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|
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.
- 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
- 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
- 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
- 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
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
|Contact: Aroonwan Lam-ubol, DDS, PhDemail@example.com|
|Contact: Dunyaporn Trachootham, DDS, PhDfirstname.lastname@example.org|
|National cancer institute||Recruiting|
|Bankok, Bangkok, Thailand|
|Contact: Peerawitch Tupwong, MD email@example.com|
|Chonburi Cancer Hospital||Recruiting|
|Cholburi, Chonburi, Thailand, 20000|
|Contact: Thapana Tungcheewinsirikul, MD firstname.lastname@example.org|
|Lopburi Cancer Hospital||Recruiting|
|Lopburi, Thailand, 15000|
|Contact: Jirasak Sukhaboon, MD 6636-621800 email@example.com|
|Maharat Nakhon Ratchasima Hospital||Recruiting|
|Nakhon Ratchasima, Thailand, 30000|
|Contact: Witee Rasiew, MD firstname.lastname@example.org|
|Principal Investigator:||Aroonwan Lam-ubol, DDS, PhD||Srinakharinwirot University|