A double-blind randomized controlled trial to verify the improvement effect of Hangeshashinto on oral mucositis and blood metabolome analysis to clarify biomarkers, Kampo medicine's proof, and to contribute to appropriate use of Kampo medicines
Not Applicable
Recruiting
- Conditions
- Head and Neck cancer
- Registration Number
- JPRN-UMIN000049103
- Lead Sponsor
- ational Cancer Center Hospital Department of Dentistry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.