lacal advanced head and neck squamous cell carcinoma
Conditions
Interventions
The patient starts the oral ingestion of half-digested state nutritional supplement(300 kcal equivalent) with/without EPA from the start date of chemical radiation therapy every day.
The patient requi
Sponsors
Nara Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven squamous cell carcinoma in resected specimen 2) Primary lesion located at oropharynx, hypopharynx, or larynx 3) Pathological stage III, IVA or IVB 4) Enable to PEG manufacture 5) No prior radiation therapy, chemotherapy, nor hormonal therapy 6) No fistule formation at the primary tumor and cervical lymph nodes 7) No distant metastasis 8) ECOG performance status (PS) of 0 or 1 9) Adequate organ functions 10)Written informed consent
Exclusion criteria
Exclusion criteria: 1) Women during pregnancy, possible pregnancy, or breast-feeding 2) Simultaneous or metachronous (within 3 months) double cancers 3) Psychiatric disease 4) Patients unsuitable for registration by decision of physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transition of nutritional status and inflammatory response | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment completion rate, Treatment completion dates, Length of stay in hospital, Progression-free survival, Overall survival | — |
Countries
Japan
Contacts
Public ContactIchiro Ota
Nara Medical University Otolaryngology-Head and Neck Surgery
Outcome results
None listed