Acupuncture for Prevention and Treatment of Oral-related Complications Caused by Radiotherapy for Head and Neck Cancer
NCT ID: NCT06272617
Last Updated: 2024-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
138 participants
INTERVENTIONAL
2023-07-25
2025-07-24
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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treatment group
verum acupuncture
verum acupuncture
a type of acupuncture which is useful
control group
sham acupuncture
sham acupuncture
a type of acupuncture which is useless
Interventions
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verum acupuncture
a type of acupuncture which is useful
sham acupuncture
a type of acupuncture which is useless
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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West China Fourth Hospital, Sichuan University
UNKNOWN
West China Hospital
OTHER
Responsible Party
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Xingchen Peng
Professor
Principal Investigators
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Xingchen Peng
Role: STUDY_DIRECTOR
West China Hospital
Locations
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West China Hospital, Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-960
Identifier Type: -
Identifier Source: org_study_id
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