Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-04-23 @ 9:21 PM
Study NCT ID:
NCT03034603
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2017-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety and Efficacy Test of Nutri-PEITC Jelly in Head and Neck Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C058305', 'term': 'phenethyl isothiocyanate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-13', 'studyFirstSubmitDate': '2017-01-25', 'studyFirstSubmitQcDate': '2017-01-25', 'lastUpdatePostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '1 month and 3 months after receiving intervention', 'description': 'Evaluation of adverse events by physical examination, blood tests, and interviewing the subjects'}, {'measure': 'Changes in Health-related quality of life score compared to baseline', 'timeFrame': 'Baseline, 1 month and 3 months after receiving intervention', 'description': 'Evaluation of Health-related quality of life by using questionnaire FACT-HN'}, {'measure': 'Changes in Tumor response compared to baseline', 'timeFrame': 'Baseline, 1 month, 3 months after receiving intervention', 'description': 'Evaluation of tumor response following RECIST criteria at 1 month and 3 months'}, {'measure': 'Progression-free survival time', 'timeFrame': 'The time of the intervention until any signs or symptoms of progressive disease be recorded.', 'description': 'The length of time during the intervention that the participant lives with stable disease'}], 'secondaryOutcomes': [{'measure': 'Serum p53 level', 'timeFrame': '1 month and 3 months after receiving intervention', 'description': 'Level of both wild type and mutant p53 in serum'}, {'measure': 'Serum cytochrome C level', 'timeFrame': '1 month and 3 months after receiving intervention', 'description': 'Level of cytochrome C in serum'}, {'measure': 'Changes in Functional status', 'timeFrame': 'Baseline, 1 month and 3 months after receiving intervention', 'description': 'Evaluation of functional status using KPS (Karnofsky Performance Score) score'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Head and Neck Neoplasms', 'Quality of Life', 'Nutrition Related Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nindependent 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of squamous cell carcinoma in areas of lip, oral cavity, oropharynx and hypopharynx, who receive only palliative care or deny definitive treatment\n2. Finished radiotherapy or/and chemotherapy for at least one month\n3. Has at least one measurable target lesion\n4. Baseline KPS ≥ 40% or ECOG 0-3\n5. 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\n6. Able to take the intervention (through mouth or NG tube) without aspiration\n7. Able to communicate and consent to the study\n\nExclusion Criteria:\n\n1. Cannot come back for the follow-up visits\n2. Receive or had received N-acetylcysteine during the intervention\n3. Has systemic diseases that might interfere with the results\n4. Chronic kidney disease that requires dialysis\n5. Increased risk of aspiration pneumonia\n6. Pregnancy or lactation\n7. Untreated infectious diseases'}, 'identificationModule': {'nctId': 'NCT03034603', 'briefTitle': 'The Safety and Efficacy Test of Nutri-PEITC Jelly in Head and Neck Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Dental Innovation Foundation Under Royal Patronage'}, 'officialTitle': 'The Safety and Efficacy Test of Nutri-PEITC Jelly in Head and Neck Cancer Patients', 'orgStudyIdInfo': {'id': 'DIF-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutri-jelly with PEITC', 'description': 'Continuous intake of 200 g Nutri-jelly with 20 mg PEITC per day, five days per week for 3 months.', 'interventionNames': ['Dietary Supplement: Nutri-jelly with PEITC']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Nutri-jelly', 'description': 'Continuous intake of 200 g Nutri-jelly per day, five days per week for 3 months.', 'interventionNames': ['Dietary Supplement: Nutri-jelly']}], 'interventions': [{'name': 'Nutri-jelly with PEITC', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Nutri-jelly with PEITC']}, {'name': 'Nutri-jelly', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Nutri-jelly is an edible nutritious gel for patients with chewing and swallowing difficulties. One milligram of Nutri-jelly contains approximately 1 kcal.', 'armGroupLabels': ['Nutri-jelly']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'National cancer institute', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '20000', 'city': 'Chon Buri', 'state': 'Changwat Chon Buri', 'country': 'Thailand', 'facility': 'Chonburi Cancer Hospital', 'geoPoint': {'lat': 13.3622, 'lon': 100.98345}}, {'zip': '15000', 'city': 'Lopburi', 'country': 'Thailand', 'facility': 'Lopburi Cancer Hospital', 'geoPoint': {'lat': 14.79808, 'lon': 100.65397}}, {'zip': '30000', 'city': 'Nakhon Ratchasima', 'country': 'Thailand', 'facility': 'Maharat Nakhon Ratchasima Hospital', 'geoPoint': {'lat': 14.97066, 'lon': 102.10196}}, {'zip': '12110', 'city': 'Pathum Thani', 'country': 'Thailand', 'facility': 'Maha Vajiralongkorn Thanyaburi Hospital', 'geoPoint': {'lat': 14.01346, 'lon': 100.53049}}], 'overallOfficials': [{'name': 'Aroonwan Lam-ubol, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Srinakharinwirot University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dental Innovation Foundation Under Royal Patronage', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mahidol University', 'class': 'OTHER'}, {'name': 'Srinakharinwirot University', 'class': 'OTHER'}, {'name': 'Ministry of Health, Thailand', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}