Head and Neck cancer
Conditions
Interventions
Gargling with hangeshashinto and oral administration during head and neck chemoradiotherapy
Gargling with placebo and oral administration during head and neck chemoradiotherapy
Sponsors
National Cancer Center Hospital Department of Dentistry
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with head and neck cancer undergoing chemoradiation therapy with an oral irradiation dose exceeding 30 Gy. (3) Patients whose performance status (ECOG classification) is 0 or 1 (4) Patients who are 18 years of age or older at the time of enrollment (5) Patients who have obtained a signed and dated consent form by the patient before enrollment in this study. (If the patient cannot write, obtain verbal consent and have a scribe write it on their behalf)
Exclusion criteria
Exclusion criteria: (1) Patients who have received kampo medicines preparations within 2 weeks prior to enrollment in this study (2) Patients who have a history of allergy to kampo medicines (3)Patients who are judged to be unsuitable for the safe conduct of this study by the research co-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration time of oral mucositis (DTM) of grade 2 or higher oral mucositis (assessed by CTCAE V5.0) during head and neck chemoradiation therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of Grade 2 or higher oral mucositis (IOM) during head and neck chemoradiation therapy. Note that the grade is not the average intraday variation, but the worst grade within the day. Time to healing of oral mucositis (THM) Adverse events other than oral mucositis (oral bleeding, oral infectious complications, etc.) (frequency, severity) Influence on treatment of primary disease Proportion of discontinuation of radiotherapy Percent reduction in chemotherapy intensity Nutritional evaluation Content and amount of oral intake Percentage requiring nutritional management such as enteral nutrition through gastrostomy or high-calorie transfusion Percentage of weight loss, percentage of decrease in blood prealbumin level Metabolome analysis in blood Chronological and exhaustive search for minute metabolites in blood Safety evaluation of hangeshashinto and placebo Presence or absence and frequency of adverse events due to the use of the study drug. | — |
Countries
Japan
Contacts
Public ContactTakao Ueno
National Cancer Center Hospital Department of Dentistry
Outcome results
None listed