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

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

Inclusion criteria

• 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

Exclusion criteria

• 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