head and neck cancer
Conditions
Interventions
Administration of Hangeshashinto(TJ-14) during chemoradiation for more than 6 weeks other than basic supportive cares for oral mucositis.
Only basic supportive cares for oral mucositis.
Sponsors
Department of Otolaryngolory-Head and Neck Surgery, National Defense Medical College of Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Stage II-IVB oral, pharyngeal or laryngeal patients. 2) Patients who undergo chemoradiatio with cisplatin of more than 60 Gy for whole neck. 3) Patients who can take Hangeshashinto (TJ-14) by mouth. 4) Performance status 0 or 1. 5) Patients meeting all crietia below in the laboratory data within 7 days before starting chemoradiation. WBC; more than 4,000/mm3, Neutrophil count; more than 1,500/mm3 Platelet count; more than 100,000/mm3 BUN, ALT, AST; less than facility criteria Creatinin clearance or correction eGFR ;less than 60ml/min 6) Inpatients.
Exclusion criteria
Exclusion criteria: 1) Patients administered other Kampo medicine within 2 weeks before registration 2) Patients who were continuously adminisiterd NSAIDs, opioids or steroids within one month before registration 3) Patients having serious comorbid disease 4) Patients administered a developing new drug 5) Pregnant patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of more than grade 3 oral mucositis by CTCAE Ver. 4.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Rates of chemoradiation completion 2) Duration of presence of more than grade 3 oral mucositis 3) Days until incidence of more than grade 3 oral mucositis 4) Total dose of opioids 5) Change of body weight 6) Nutrition status 7) Use of tube feeding 8) Grade of Dry mouth by CTCAE version 4.0 more than 6 months after chemoradiation | — |
Countries
Japan
Contacts
Public ContactTaku Yamashita
National Defense Medical College of Japan Department of Otolaryngolory-Head and Neck Surgery
Outcome results
None listed