Radioprotective Effect of Chinese Herbal Medicine on Oral Mucositis

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05040425
• Other study ID #: 202101231A3
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 30, 2021
• Est. completion date: April 1, 2023

Study information

• Verified date: August 2021
• Source: Chang Gung Memorial Hospital
• Contact: Ming-Yen Tsai, PhD
• Phone: +886975056534
• Email: missuriae[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 1, 2023
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	National Research Institute of Chinese Medicine, Ministry of Health and Welfare

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Traditional Chinese medicine constitution	Body Constitution Questionnaire (BCQ)	Baseline, 4th week, and 6th week of radiotherapy completion
Other	Electrical body conductivity	Meridian Energy Analysis Device	Baseline, 4th week, and 6th week of radiotherapy completion
Primary	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
Primary	Mucositis pain	100-mm-visual analog scale (VAS, 0-100)	During the radiotherapy course, up to 6 weeks
Secondary	Health related-QoL (1)	EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)	Baseline, 4th week, and 6th week of radiotherapy completion
Secondary	Health related-QoL (2)	Quality of Life Head and Neck Module (QLQ-H&N35)	Baseline, 4th week, and 6th week of radiotherapy completion
Secondary	Body mass index (BMI)	Body mass index (BMI)	During the radiotherapy course, up to 6 weeks