Therapeutic effectiveness of Yeoldahanso-tang on radiation induced oral mucositis in head and neck cancer patients
- Conditions
- Not Applicable
- Registration Number
- KCT0002022
- Lead Sponsor
- Kyung Hee University Oriental Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 46
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)