Radioprotective Effect of Chinese Herbal Medicine on Oral Mucositis

Chang Gung Memorial Hospital200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

200

Conditions

Head and Neck Cancer Oral Mucositis

Interventions

Zi-Yin-Liang-Ge-SanDRUG

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).

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Degree of oral mucositis

The degree was graded by the NHI Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)

Time frame: During the radiotherapy course, up to 6 weeks

Mucositis pain

100-mm-visual analog scale (VAS, 0-100)

Time frame: During the radiotherapy course, up to 6 weeks

Secondary Outcomes

Health related-QoL (1)

EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)

Time frame: Baseline, 4th week, and 6th week of radiotherapy completion

Health related-QoL (2)

Quality of Life Head and Neck Module (QLQ-H\&N35)

Time frame: Baseline, 4th week, and 6th week of radiotherapy completion

Body mass index (BMI)

Time frame: During the radiotherapy course, up to 6 weeks

Central Contacts

Ming-Yen Tsai, PhD

CONTACT

+886975056534 missuriae@yahoo.com.tw

Data from ClinicalTrials.gov

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