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

A Single-center, Single-blind Phase II Clinical Trial of Acupuncture for the Prevention and Treatment of Oral-related Complications Caused by Radiotherapy for Head and Neck Malignant Tumors

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

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.

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