None listed
Conditions
Interventions
Drug : Experimental grooup is YDHST(Yeoldahanso-tang) group, will receive YDHST(Yeoldahanso-tang) granules 5 g/pouch, 3 times per day—after each meal—for 6 weeks. Yeoldahanso-tang is brown granules wh
Sponsors
Kyung Hee University Oriental Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 19 years 2. Patients who have plan to receive radiotherapy 50 Gy or above for head and neck cancer 3. The Eastern Cooperative Oncology Group (ECOG) performance status = 2 4. Patients diagnosed with Taeeum type by the Questionnaire for Sasang Constitutional Classification ? + (QSCC?+) and Korean medicine doctor 5. Patients who consent to intervention protocol with no other treatment about oral mucositis 6. Written informed consent
Exclusion criteria
Exclusion criteria: 1. History of previous radiotherapy to the head and neck lesion 2. Unhealed wound in the radiation field 3. Concurrent chemotherapy during radiotherapy 4. History of connective tissue disorder 5. Distant metastasis 6. AST > 2-fold of upper normal limit or ALT > 2-fold of upper normal limit at screening 7. Serum Creatinine = 1.7 ?/? at screening 8. Taking other clinical trial medicine during the previous 4 weeks 9. History of hypersensitivity reaction to medicine or addition agents 10. Severe medical problems that would affect clinical trial 11. Patients who undergo radical surgery within 2 week before the start of radiotherapy 12. Patient who have plan to receive any other cancer treatment modality (immunotherapy, hyperthermia, or traditional Korean medicine therapy) except radiotherapy 13. Severe dental problems (periodontal disease caused bleeding and facial edema, heand and neck fasciitis ) 14. Impaired mental status that would prohibit the understanding and giving of informed consent 15. Pregnant or lactating women 16. Patients who are not able to undergo clinical trial according to the physician’s judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the incidence rate of severe radiation-induced oral mucositis ( more than grade 3 according to the radiation therapy oncology group (RTOG) acute radiation morbidity scoring criteria) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation for radiation-induced oral mucositis (incidence rate, medican duration)/ via radiation therapy oncology group (RTOG) grade scale;Evaluation for dry mouth / via Common Terminology Criteria for Adverse Events (CTCAE) version 4.0;evaluation for salivary secretory function via sailmetry;Quality of life evaluation (European Organization for Research and Treatment of Cancer Quality of Life Questionnare Head and Neck 35, EORTC QLQ-HN35);Pain evaluation;Cold-Heat Pattern Identification ;Deficiency Syndrome Questionnaire ( qi deficiency, blood deficiency, yin deficiency, yang deficiency);Safety test(blood test, urine test) | — |
Countries
Korea, Republic of
Contacts
Public ContactKwan-Il Kim
Kyung Hee University Oriental Medical Center
Outcome results
None listed