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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05040425
Other study ID # 202101231A3
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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