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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | verum acupuncture |
|
| control group | Sham Comparator | sham acupuncture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| verum acupuncture | Device | a type of acupuncture which is useful |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Xerostomia questionnaire scores | Patients self-evaluated xerostomia according to Xerostomia questionnaire(score 0-100);Higher score indicates more severe symptoms | 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary flow rate | Researchers-measured unstimulated and stimulated salivary flow rates;Lower value indicates more severe symptoms | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingchen Peng | Contact | +8618980606753 | pxx2014@scu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xingchen Peng | West China Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | China |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| sham acupuncture |
| Device |
a type of acupuncture which is useless |
|
Assessed by Patients self-evaluated dysgeusia(score 19-95);Higher score indicates more severe symptoms |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | up to 12 months |
| Changes of oral flora | The changes of oral flora in patients' salivary or oral swab measured by 16s rDNA technique | 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 | 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 | 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment |