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| Name | Class |
|---|---|
| Mahidol University | OTHER |
| Srinakharinwirot University | OTHER |
| Ministry of Health, Thailand | OTHER_GOV |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Nutri-jelly | Placebo Comparator | Continuous intake of 200 g Nutri-jelly per day, five days per week for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum p53 level | Level of both wild type and mutant p53 in serum | 1 month and 3 months after receiving intervention |
| Serum cytochrome C level | Level of cytochrome C in serum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aroonwan Lam-ubol, DDS, PhD | Srinakharinwirot University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National cancer institute | Bangkok | Bangkok | Thailand | |||
| Chonburi Cancer Hospital |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C058305 | phenethyl isothiocyanate |
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| 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. |
|
| 1 month and 3 months after receiving intervention |
| Changes in Functional status | Evaluation of functional status using KPS (Karnofsky Performance Score) score | Baseline, 1 month and 3 months after receiving intervention |
| Chon Buri |
| Changwat Chon Buri |
| 20000 |
| Thailand |
| Lopburi Cancer Hospital | Lopburi | 15000 | Thailand |
| Maharat Nakhon Ratchasima Hospital | Nakhon Ratchasima | 30000 | Thailand |
| Maha Vajiralongkorn Thanyaburi Hospital | Pathum Thani | 12110 | Thailand |