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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-25

Study Completion Date

2025-07-24

Brief Summary

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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

Detailed Description

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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.

Conditions

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Malignant Tumor of Head and/or Neck Radiotherapy; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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treatment group

verum acupuncture

Group Type EXPERIMENTAL

verum acupuncture

Intervention Type DEVICE

a type of acupuncture which is useful

control group

sham acupuncture

Group Type SHAM_COMPARATOR

sham acupuncture

Intervention Type DEVICE

a type of acupuncture which is useless

Interventions

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verum acupuncture

a type of acupuncture which is useful

Intervention Type DEVICE

sham acupuncture

a type of acupuncture which is useless

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Fourth Hospital, Sichuan University

UNKNOWN

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xingchen Peng

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Xingchen Peng

Role: CONTACT

+8618980606753

Facility Contacts

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Xingchen Peng

Role: primary

0086-18980606753

Other Identifiers

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2023-960

Identifier Type: -

Identifier Source: org_study_id

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