Radioprotective Effect of Chinese Herbal Medicine on Oral Mucositis
Primary Purpose
Head and Neck Cancer, Oral Mucositis
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Zi-Yin-Liang-Ge-San
Sponsored by
About this trial
This is an interventional prevention trial for Head and Neck Cancer focused on measuring Oral mucositis, Radiotherapy, Head and neck cancer, Chinese herbal medicine, Randomized trial
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Chinese herbal medicine treatment
Non-Chinese herbal medicine treatment
Arm Description
Outcomes
Primary Outcome Measures
Degree of oral mucositis
The degree was graded by the NHI Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
Mucositis pain
100-mm-visual analog scale (VAS, 0-100)
Secondary Outcome Measures
Health related-QoL (1)
EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)
Health related-QoL (2)
Quality of Life Head and Neck Module (QLQ-H&N35)
Body mass index (BMI)
Body mass index (BMI)
Full Information
NCT ID
NCT05040425
First Posted
September 3, 2021
Last Updated
September 7, 2021
Sponsor
Chang Gung Memorial Hospital
Collaborators
National Research Institute of Chinese Medicine, Ministry of Health and Welfare
1. Study Identification
Unique Protocol Identification Number
NCT05040425
Brief Title
Radioprotective Effect of Chinese Herbal Medicine on Oral Mucositis
Official Title
Radioprotective Effect of Chinese Herbal Medicine on Ionizing Radiation-Induced Oral Mucositis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2021 (Anticipated)
Primary Completion Date
August 17, 2022 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
National Research Institute of Chinese Medicine, Ministry of Health and Welfare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Oral Mucositis
Keywords
Oral mucositis, Radiotherapy, Head and neck cancer, Chinese herbal medicine, Randomized trial
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chinese herbal medicine treatment
Arm Type
Experimental
Arm Title
Non-Chinese herbal medicine treatment
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Zi-Yin-Liang-Ge-San
Intervention Description
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).
Primary Outcome Measure Information:
Title
Degree of oral mucositis
Description
The degree was graded by the NHI Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
Time Frame
During the radiotherapy course, up to 6 weeks
Title
Mucositis pain
Description
100-mm-visual analog scale (VAS, 0-100)
Time Frame
During the radiotherapy course, up to 6 weeks
Secondary Outcome Measure Information:
Title
Health related-QoL (1)
Description
EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)
Time Frame
Baseline, 4th week, and 6th week of radiotherapy completion
Title
Health related-QoL (2)
Description
Quality of Life Head and Neck Module (QLQ-H&N35)
Time Frame
Baseline, 4th week, and 6th week of radiotherapy completion
Title
Body mass index (BMI)
Description
Body mass index (BMI)
Time Frame
During the radiotherapy course, up to 6 weeks
Other Pre-specified Outcome Measures:
Title
Traditional Chinese medicine constitution
Description
Body Constitution Questionnaire (BCQ)
Time Frame
Baseline, 4th week, and 6th week of radiotherapy completion
Title
Electrical body conductivity
Description
Meridian Energy Analysis Device
Time Frame
Baseline, 4th week, and 6th week of radiotherapy completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Yen Tsai, PhD
Phone
+886975056534
Email
missuriae@yahoo.com.tw
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The datasets during and/or analyzed during the current study available from the corresponding author on reasonable request.
Learn more about this trial
Radioprotective Effect of Chinese Herbal Medicine on Oral Mucositis
We'll reach out to this number within 24 hrs