Clinical trial · Interventional
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
NCT06272617CI-TRIAL-00074254unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Tumor of Head and/or Neck | Head and Neck Neoplasm | PROBABILISTIC | 0.70 |
| Radiotherapy; Complications | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sham acupuncture | Device | — | UNRESOLVED |
| verum acupuncture | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- treatment group
- description
- verum acupuncture
- interventionNames
- Device: verum acupuncture
- type
- SHAM_COMPARATOR
- label
- control group
- description
- sham acupuncture
- interventionNames
- Device: sham acupuncture
Primary outcomes (1)
- measure
- Xerostomia questionnaire scores
- timeFrame
- 1 week before radiotherapy;weekly during the treatment(every 5 radiotherapy sessions);1, 3, 6, 12 months after the end of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.