Clinical trial NCT05040425: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Head and Neck Cancer
Oral Mucositis
Keywords: Oral mucositis
Radiotherapy
Head and neck cancer
Chinese herbal medicine
Randomized trial
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Research Institute of Chinese Medicine, Ministry of Health and Welfare
First posted: 2021-09-10
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Degree of oral mucositis
timeFrame: During the radiotherapy course, up to 6 weeks
measure: Mucositis pain
timeFrame: During the radiotherapy course, up to 6 weeks
Secondary outcomes:
measure: Health related-QoL (1)
timeFrame: Baseline, 4th week, and 6th week of radiotherapy completion
measure: Health related-QoL (2)
timeFrame: Baseline, 4th week, and 6th week of radiotherapy completion
measure: Body mass index (BMI)
timeFrame: During the radiotherapy course, up to 6 weeks
Other outcomes:
measure: Traditional Chinese medicine constitution
timeFrame: Baseline, 4th week, and 6th week of radiotherapy completion
measure: Electrical body conductivity
timeFrame: Baseline, 4th week, and 6th week of radiotherapy completion
Locations:
Study officials:
References: