Clinical trial · Interventional
The Safety and Efficacy Test of Nutri-PEITC Jelly in Head and Neck Cancer Patients
NCT03034603CI-TRIAL-00063943completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Nutrition Related Cancer | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nutri-jelly | Dietary Supplement | — | UNRESOLVED |
| Nutri-jelly with PEITC | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- 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
Primary outcomes (4)
- measure
- Adverse events
- timeFrame
- 1 month and 3 months after receiving intervention
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.