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Acupuncture for Prevention and Treatment of Oral-related Complications Caused by Radiotherapy for Head and Neck Cancer

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06272617
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 West China Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Xingchen Peng
Principal Investigator Affiliation West China Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Malignant Tumor of Head and/or Neck, Radiotherapy; Complications
Additional Details

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.

Arms & Interventions

Arms

Experimental: treatment group

verum acupuncture

Sham Comparator: control group

sham acupuncture

Interventions

Device: - verum acupuncture

a type of acupuncture which is useful

Device: - sham acupuncture

a type of acupuncture which is useless

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

West China Hospital, Sichuan University, Chengdu, Sichuan, China

Status

Recruiting

Address

West China Hospital, Sichuan University

Chengdu, Sichuan,

Site Contact

Xingchen Peng

[email protected]

0086-18980606753

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