Radioprotective Effect of Chinese Herbal Medicine on Oral Mucositis

NCT ID: NCT05040425

Last Updated: 2021-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-30
• Study Completion Date: 2023-04-01

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.

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.

Conditions

Head and Neck Cancer; Oral Mucositis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Chinese herbal medicine treatment

Group Type: EXPERIMENTAL

Zi-Yin-Liang-Ge-San

Intervention Type: DRUG

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).

Non-Chinese herbal medicine treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Research Institute of Chinese Medicine, Ministry of Health and Welfare

OTHER_GOV

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ming-Yen Tsai, PhD

Role: CONTACT

missuriae@yahoo.com.tw

+886975056534

Other Identifiers

202101231A3

Identifier Type: -

Identifier Source: org_study_id