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| Name | Class |
|---|---|
| National Research Institute of Chinese Medicine, Ministry of Health and Welfare | OTHER_GOV |
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This protocol describes a randomized, double-arm, parallel-group, open-label controlled study that aims to evaluate the efficacy of Chinese herbal medicine on head and neck cancer patients with oral mucositis toxicities and quality of life during radiotherapy.
200 head and neck cancer patients who were scheduled for radiotherapy are randomly assigned at a 1:1 ratio to two arms: control group and those treated with Zi-Yin-Liang-Ge-San containing Rx. Scutellariae, Rx. Glycyrrhizae, Hb. Dendrobii, Rx. Ophiopogonis, and Hb. Menthae Haplocalycis from day 1 of radiotherapy. The study lasted at least 6 weeks and the clinical benefit was determined by onset, gradation of mucositis (Common Terminology Criteria for Adverse Events v5.0), oral pain (visual analysis scale) for each week during RT. Nutritional status, EORTC Quality of Life Core Questionnaire (QLQ-C30) and head and neck module (QLQ-H&N35), Body Constitution Questionnaire (BCQ), and electrical body conductivity were evaluated before and after radiotherapy. Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE), serious adverse events, blood and biochemical analysis will be recorded to evaluate the safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chinese herbal medicine treatment | Experimental |
| |
| Non-Chinese herbal medicine treatment | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zi-Yin-Liang-Ge-San | Drug | Zi-Yin-Liang-Ge-San is composed of five herb ingredients, namely Rx. Scutellariae (Huang Qin), Rx. Glycyrrhizae (Gan Cao), Hb. Dendrobii (Shi Hu), Rx. Ophiopogonis (Mai Men Dong), and Hb. Menthae Haplocalycis (Bo He). It is orally administrated trice daily from the first day to the end of RT in the treatment group, aiming to prevent and manage the OM. ZYLGS is manufactured as a concentrated herbal extract, constituted 4 g per packet, and origin from pharmaceutical companies in Taiwan with good manufacturing practice (GMP). |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of oral mucositis | The degree was graded by the NHI Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) | During the radiotherapy course, up to 6 weeks |
| Mucositis pain | 100-mm-visual analog scale (VAS, 0-100) | During the radiotherapy course, up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Health related-QoL (1) | EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) | Baseline, 4th week, and 6th week of radiotherapy completion |
| Health related-QoL (2) | Quality of Life Head and Neck Module (QLQ-H&N35) |
| Measure | Description | Time Frame |
|---|---|---|
| Traditional Chinese medicine constitution | Body Constitution Questionnaire (BCQ) | Baseline, 4th week, and 6th week of radiotherapy completion |
| Electrical body conductivity | Meridian Energy Analysis Device |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming-Yen Tsai, PhD | Contact | +886975056534 | missuriae@yahoo.com.tw |
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The datasets during and/or analyzed during the current study available from the corresponding author on reasonable request.
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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The participants selected at screening who provide written informed consent will be randomly allocated to two groups. One will be submitted to Chinese herbal medicine group, and the other to control group.
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| Baseline, 4th week, and 6th week of radiotherapy completion |
| Body mass index (BMI) | Body mass index (BMI) | During the radiotherapy course, up to 6 weeks |
| Baseline, 4th week, and 6th week of radiotherapy completion |