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Trial Title:
Acupuncture for Prevention and Treatment of Oral-related Complications Caused by Radiotherapy for Head and Neck Cancer
NCT ID:
NCT06272617
Condition:
Malignant Tumor of Head and/or Neck
Radiotherapy; Complications
Conditions: Official terms:
Neoplasms
Head and Neck Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Device
Intervention name:
verum acupuncture
Description:
a type of acupuncture which is useful
Arm group label:
treatment group
Intervention type:
Device
Intervention name:
sham acupuncture
Description:
a type of acupuncture which is useless
Arm group label:
control group
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Xingchen Peng
Phone:
0086-18980606753
Email:
pxx2014@scu.edu.cn
Start date:
July 25, 2023
Completion date:
July 24, 2025
Lead sponsor:
Agency:
West China Hospital
Agency class:
Other
Collaborator:
Agency:
West China Fourth Hospital, Sichuan University
Agency class:
Other
Source:
West China Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06272617
