Acupuncture for oral complications from head and neck cancer treatment
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
NA · West China Hospital · NCT06272617
This study tests whether acupuncture can help people with head and neck cancer who are getting radiation therapy by reducing oral problems like dry mouth and discomfort.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | West China Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06272617 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of acupuncture in preventing and treating oral-related complications in patients with head and neck malignant tumors undergoing radiotherapy. Participants will be randomly assigned to receive either real acupuncture or sham acupuncture, allowing researchers to compare the outcomes between the two groups. The study aims to determine whether acupuncture can effectively alleviate complications associated with radiotherapy, such as dry mouth and oral discomfort. The trial will also assess the safety of acupuncture in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with malignant tumors of the head and neck who are receiving radiotherapy.
Not a fit: Patients with a history of dry mouth, Sjogren's syndrome, or other conditions causing dry mouth may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive treatment option to alleviate oral complications for patients undergoing radiotherapy for head and neck cancer.
How similar studies have performed: Other studies have shown promising results for acupuncture in managing treatment-related complications, suggesting potential efficacy in this area.
Eligibility criteria
Show full 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
Where this trial is running
Chengdu, Sichuan
- West China Hospital, Sichuan University — Chengdu, Sichuan, China (RECRUITING)
Study contacts
- Study coordinator: Xingchen Peng
- Email: pxx2014@scu.edu.cn
- Phone: +8618980606753
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Malignant Tumor of Head and/or Neck, Radiotherapy, Complications