Clinical trial NCT03034603: The Safety and Efficacy Test of Nutri-PEITC Jelly in Head and Neck Cancer Patients
Official title: The Safety and Efficacy Test of Nutri-PEITC Jelly in Head and Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Neoplasms
Quality of Life
Nutrition Related Cancer
Lead sponsor: Dental Innovation Foundation Under Royal Patronage
Sponsor class: OTHER
Collaborators: name: Mahidol University
name: Srinakharinwirot University
name: Ministry of Health, Thailand
First posted: 2017-01-27
Enrollment: 96
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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, progression-free survival, serum p53 and cytochrome C levels and functional status

Eligibility 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

Primary outcomes:
measure: Adverse events
timeFrame: 1 month and 3 months after receiving intervention
measure: Changes in Health-related quality of life score compared to baseline
timeFrame: Baseline, 1 month and 3 months after receiving intervention
measure: Changes in Tumor response compared to baseline
timeFrame: Baseline, 1 month, 3 months after receiving intervention
measure: Progression-free survival time
timeFrame: The time of the intervention until any signs or symptoms of progressive disease be recorded.
Secondary outcomes:
measure: Serum p53 level
timeFrame: 1 month and 3 months after receiving intervention
measure: Serum cytochrome C level
timeFrame: 1 month and 3 months after receiving intervention
measure: Changes in Functional status
timeFrame: Baseline, 1 month and 3 months after receiving intervention
Other outcomes:
Locations:
city: Bankok
country: Thailand
facility: National cancer institute
state: Bangkok
city: Cholburi
country: Thailand
facility: Chonburi Cancer Hospital
state: Chonburi
city: Lopburi
country: Thailand
facility: Lopburi Cancer Hospital
city: Nakhon Ratchasima
country: Thailand
facility: Maharat Nakhon Ratchasima Hospital
city: Pathum Thani
country: Thailand
facility: Maha Vajiralongkorn Thanyaburi Hospital
Study officials:
affiliation: Srinakharinwirot University
name: Aroonwan Lam-ubol, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: