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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06272617
Other study ID # 2023-960
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 25, 2023
Est. completion date July 24, 2025

Study information

Verified date February 2024
Source West China Hospital
Contact Xingchen Peng
Phone +8618980606753
Email pxx2014@scu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 138
Est. completion date July 24, 2025
Est. primary completion date July 24, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Device:
verum acupuncture
a type of acupuncture which is useful
sham acupuncture
a type of acupuncture which is useless

Locations

Country Name City State
China West China Hospital, Sichuan University Chengdu Sichuan

Sponsors (2)

Lead Sponsor Collaborator
West China Hospital West China Fourth Hospital, Sichuan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary Taste function assessed by patients 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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