Radioprotective Effect of Chinese Herbal Medicine on Oral Mucositis

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05040425

Collaborator

National Research Institute of Chinese Medicine, Ministry of Health and Welfare (Other)

200

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer Oral Mucositis	Drug: Zi-Yin-Liang-Ge-San	Phase 2

Detailed 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

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Aug 30, 2021

Anticipated Primary Completion Date :

Aug 17, 2022

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chinese herbal medicine treatment	Drug: Zi-Yin-Liang-Ge-San 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).
No Intervention: Non-Chinese herbal medicine treatment

Arm

Intervention/Treatment

Experimental: Chinese herbal medicine treatment

Drug: Zi-Yin-Liang-Ge-San

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).

No Intervention: Non-Chinese herbal medicine treatment

Outcome Measures

Primary Outcome Measures

Degree of oral mucositis [During the radiotherapy course, up to 6 weeks]
The degree was graded by the NHI Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
Mucositis pain [During the radiotherapy course, up to 6 weeks]
100-mm-visual analog scale (VAS, 0-100)

Secondary Outcome Measures

Health related-QoL (1) [Baseline, 4th week, and 6th week of radiotherapy completion]
EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)
Health related-QoL (2) [Baseline, 4th week, and 6th week of radiotherapy completion]
Quality of Life Head and Neck Module (QLQ-H&N35)
Body mass index (BMI) [During the radiotherapy course, up to 6 weeks]
Body mass index (BMI)

Other Outcome Measures

Traditional Chinese medicine constitution [Baseline, 4th week, and 6th week of radiotherapy completion]
Body Constitution Questionnaire (BCQ)
Electrical body conductivity [Baseline, 4th week, and 6th week of radiotherapy completion]
Meridian Energy Analysis Device

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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