A study on the efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors
The goal of this clinical trial is to investigate the efficacy and safety of acupuncture for oral-related complications in patients with head and neck malignant tumors who receive radiotherapy. The main questions it aims to answer are: * the efficacy of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors * the safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors Participants will: * be treated with real acupuncture or sham acupuncture * be evaluated to learn the efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors Researchers will compare real acupuncture group with sham acupuncture group to see if acupuncture has good efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
138
a type of acupuncture which is useful
a type of acupuncture which is useless
West China Hospital, Sichuan University
Chengdu, Sichuan, China
RECRUITINGXerostomia questionnaire scores
Patients self-evaluated xerostomia according to Xerostomia questionnaire(score 0-100);Higher score indicates more severe symptoms
Time frame: 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Salivary flow rate
Researchers-measured unstimulated and stimulated salivary flow rates;Lower value indicates more severe symptoms
Time frame: 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Taste function assessed by patients
Assessed by Patients self-evaluated dysgeusia(score 19-95);Higher score indicates more severe symptoms
Time frame: 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Taste function assessed by electrogustometer test
Assessed by electrogustometer test(score -6 to 34);Higher score indicates more severe symptoms
Time frame: 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Taste function assessed by taste strips test
Assessed by taste strips test(score 0-16);Lower score indicates more severe symptoms
Time frame: 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Oral mucositis
Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale(grade 1-5);Higher grade indicates more severe symptoms
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Time frame: 1 week before radiotherapy;twice a week during the treatment(usually every 3 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Dysphagia
Dysphagia is assessed by M.D.Anderson Dysphagia Inventory(score 20-100);Lower score indicates more severe symptoms
Time frame: 1 week before radiotherapy;at the middle of treatment(3 weeks after the start of radiotherapy);at the end of treatment(the last radiation dose received, usually 6 or 6.5 weeks);1, 3, 6, 12 months after the end of treatment
Quality of Life assessed by EORTC QLQ-C30
Quality of Life is assessed by EORTC QLQ-C30(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire);transformed into 0-100 scales for different domains and symptoms;Higher domain scores represent better quality of life, while higher symptom scores represent worse quality of life
Time frame: 1 week before radiotherapy;at the middle of treatment(3 weeks after the start of radiotherapy);at the end of treatment(the last radiation dose received, usually 6 or 6.5 weeks);1, 3, 6, 12 months after the end of treatment
Quality of Life assessed by QLQ-H&N35
Quality of Life is assessed by QLQ-H\&N35(Head and neck cancer-related quality of life scale);transformed into 0-100 scales for different domains and symptoms;Higher scores represent worse quality of life
Time frame: 1 week before radiotherapy;at the middle of treatment(3 weeks after the start of radiotherapy);at the end of treatment(the last radiation dose received, usually 6 or 6.5 weeks);1, 3, 6, 12 months after the end of treatment
Adverse effects
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version(grade 1-5);Higher grade indicates more severe symptoms
Time frame: up to 12 months
Changes of oral flora
The changes of oral flora in patients' salivary or oral swab measured by 16s rDNA technique
Time frame: 1 week before radiotherapy;at the middle of treatment(3 weeks after the start of radiotherapy);at the end of treatment(the last radiation dose received, usually 6 or 6.5 weeks);1, 3, 6, 12 months after the end of treatment
Tongue range of motion
Assessed by Tongue Range of Motion Assessment Scale(score 0-100);Lower score indicates more severe symptoms
Time frame: 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Neck Fibrosis
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version:Fibrosis skin(grade 1-5);Higher grade indicates more severe symptoms
Time frame: 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment