Malignant Tumor of Head and/or Neck, Radiotherapy; Complications
Conditions
Brief summary
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
Detailed description
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.
Interventions
DEVICEverum acupuncture
a type of acupuncture which is useful
DEVICEsham acupuncture
a type of acupuncture which is useless
Sponsors
West China Fourth Hospital, Sichuan University
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with malignant tumors of the head and neck without metastasis * Age ≥18, ≤80 years old * ZPS score ≤2 * Receiving radiotherapy alone or concurrent radiotherapy with a radiation dose of \>50 Gy, including at least one parotid gland * Judged to be able to receive acupuncture treatment, with all needle positions identified as accessible * Signed informed consent form
Exclusion criteria
* History of dry mouth, Sjogren's syndrome, or other underlying systemic condition known to cause dry mouth * Suspected or confirmed physical closure of both salivary gland ducts * Have a phobia of needles or prohibit the use of acupuncture at any acupuncture points * Have a history of head and neck radiotherapy * Have contraindications to acupuncture, including but not limited to bleeding disorders, having skin infections, ulcers or frequent infections * Have taken any medications or herbs within the past 30 days that may affect salivary function, plan to or eventually take such substances during the study period * Poor oral hygiene or severe periodontitis * Poor compliance * Other patients who, in the opinion of the investigator, are not suitable for participation in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Xerostomia questionnaire scores | 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment | Patients self-evaluated xerostomia according to Xerostomia questionnaire(score 0-100);Higher score indicates more severe symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Salivary flow rate | 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment | Researchers-measured unstimulated and stimulated salivary flow rates;Lower value indicates more severe symptoms |
| Taste function assessed by electrogustometer test | 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment | Assessed by electrogustometer test(score -6 to 34);Higher score indicates more severe symptoms |
| Taste function assessed by taste strips test | 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment | Assessed by taste strips test(score 0-16);Lower score indicates more severe symptoms |
| Oral mucositis | 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 | 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 |
| Dysphagia | 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 | Dysphagia is assessed by M.D.Anderson Dysphagia Inventory(score 20-100);Lower score indicates more severe symptoms |
| Taste function assessed by patients | 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment | Assessed by Patients self-evaluated dysgeusia(score 19-95);Higher score indicates more severe symptoms |
| Quality of Life assessed by QLQ-H&N35 | 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 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 |
| Adverse effects | up to 12 months | Assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version(grade 1-5);Higher grade indicates more severe symptoms |
| Changes of oral flora | 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 | The changes of oral flora in patients' salivary or oral swab measured by 16s rDNA technique |
| Tongue range of motion | 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment | Assessed by Tongue Range of Motion Assessment Scale(score 0-100);Lower score indicates more severe symptoms |
| Neck Fibrosis | 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment | Assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version:Fibrosis skin(grade 1-5);Higher grade indicates more severe symptoms |
| Quality of Life assessed by EORTC QLQ-C30 | 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 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 |
Countries
China
Contacts
Primary ContactXingchen Peng
Outcome results
None listed