Oropharyngeal or hypopharyngeal squamous cekk carcinoma
Conditions
Interventions
Oral administration of Hangeshashinto 7.5g/day t.i.d. after meals.
Sponsors
Hokkaido University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with histologically or cytologically confirmed squamous cell carcinoma of oropharynx or hypopharynx. 2) Patients who will receive chemotherapy and radiotherapy. 3) Patients who can take TJ-14 4) An Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 5) Age more than or equal to 20 years at the time of providing informed consent. 6) A life expectancy of more than 12 weeks from. 7) Confirmed by the following data obtained in the 7 days before registration. hematopoietic function white blood cell count over 4,000/mm3. neutrophil count over 1.500/mm3. platelet count over 100,000/mm3. renal function urea nitrogen level below the institutional upper limit of normal. serum creatinine level below the institutional upper limit of normal or creatinine clearance over 60 ml/min liver function aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase levels less than 2 times the institutional upper limit of normal. 8) Patients who will be Hospitalized 9) Written informed consent before initiation of study related procedures.
Exclusion criteria
Exclusion criteria: 1) Patients with serious complications (liver, kidney, heart, blood, or metabolic disorders etc.). 2) Patients who had used traditional Japanese medicines (Kampo) within 2 weeks before registration. 3) Patients who had received antiphlogistic analgetic, opioid, or steroid continuously within 1 month before registration. 4) Patients with planning or during treatment of investigational drug. 5) Chronic constipation. 6) Patients with pregnant, considering pregnancy or lactation. 7) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of mucositis (more than grade 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Nutrition index Opioid use Use of feeding tube Oral pain | — |
Countries
Japan
Outcome results
None listed