Radioprotective Effect of Chinese Herbal Medicine on Oral Mucositis

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05040425
Study type	Interventional
Source	Chang Gung Memorial Hospital
Contact	Ming-Yen Tsai, PhD
Phone	+886975056534
Email	missuriae@yahoo.com.tw
Status	Not yet recruiting
Phase	Phase 2
Start date	August 30, 2021
Completion date	April 1, 2023

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