Head and Neck Cancer, Oral Mucositis
Conditions
Keywords
Oral mucositis, Radiotherapy, Head and neck cancer, Chinese herbal medicine, Randomized trial
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.
Interventions
DRUGZi-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).
Sponsors
National Research Institute of Chinese Medicine, Ministry of Health and Welfare
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Health related-QoL (1) | Baseline, 4th week, and 6th week of radiotherapy completion | EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) |
| Body mass index (BMI) | During the radiotherapy course, up to 6 weeks | Body mass index (BMI) |
| Health related-QoL (2) | Baseline, 4th week, and 6th week of radiotherapy completion | Quality of Life Head and Neck Module (QLQ-H&N35) |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactMing-Yen Tsai, PhD
Outcome results
None listed