Radioprotective Effect of Chinese Herbal Medicine on Oral Mucositis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Radioprotective Effect of Chinese Herbal Medicine on Ionizing Radiation-Induced Oral Mucositis

Conditions
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Head and Neck Cancer, Oral Mucositis

Intervention / Treatment
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* Drug: Zi-Yin-Liang-Ge-San


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven stage II-IV squamous HNC Indication for radiotherapy or radio-chemotherapy No history of antitumor therapies No history of oral ulcer and salivary gland diseases Normal vital signs (body temperature: 36 to 37.5∘C, heart rate: 60 to 100 beats per minute, respiratory rate: <20 per minute, and mean arterial pressure: 70 to 100mmHg), and Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Exclusion Criteria: Terminal cancer for which aggressive treatments were not suitable Impaired renal or hepatic function at initial diagnosis (including chronic kidney disease stages III, IV, and V and Aspartate transaminase (AST), Alanine aminotransferase (ALT) ≥5 × the upper normal limit) Uncontrolled psychiatric problems or altered mental status Had received medications for other clinical trials

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chinese herbal medicine treatment<br> | Drug: Zi-Yin-Liang-Ge-San<br>* 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).<br>|
| No Intervention: Non-Chinese herbal medicine treatment<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral mucositis, Radiotherapy, Head and neck cancer, Chinese herbal medicine, Randomized trial