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

Sichuan University

Status: Enrolling

Conditions: Malignant Tumor of Head and/or Neck; Radiotherapy; Complications

Treatments: Device: sham acupuncture; Device: verum acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06272617

2023-960

Details and patient eligibility

About

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

Full 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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

138 participants in 2 patient groups

treatment group

Experimental group

Description:

verum acupuncture

Treatment:

Device: verum acupuncture

control group

Sham Comparator group

Description:

sham acupuncture

Treatment:

Device: sham acupuncture