Clinical trial · Interventional
Efficacy of Acupuncture in Radiotherapy-induced Dysphagia in Patients With Head and Neck Cancer
NCT03336775CI-TRIAL-00042882unknownN/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)
Purpose: Rationale: Acupuncture is a therapy for physical activity disorders secondary to nervous diseases, and it may have therapeutic effects on dysphagia caused by radiation therapy. Purpose: This randomized trial aims to investigate whether acupuncture may alleviate radiation-induced dysphagia in patients with head and neck cancer. The effect was compared with outcomes in patients without receiving acupuncture.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acupuncture | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acupuncture | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- acupuncture
- description
- Patients receive acupuncture for 30 minutes per day for up to 20 sessions (over 4 weeks). These patients also received corticosteroid for 4 weeks, methylprednisolone 80mg ivdrip. for 3 days, 60mg ivdrip. for 3 days, 40mg ivdrip. for 3 days, 30mg po. for 7 days, 20mg po. for 7 days, 10mg po. for 5 days and maintain.
- interventionNames
- Procedure: acupuncture
- type
- NO_INTERVENTION
- label
- control
- description
- Patients receive no acupuncture. The use of corticosteroid is the same with Arm I.
Primary outcomes (1)
- measure
- The change of Videofluoroscopic Dysphagia Scale (VDS) from baseline to week 4.
- timeFrame
- Assessed at baseline and week 4 during acupuncture treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have received radiation therapy for histologically confirmed head and neck cancer; 2. Prior irradiation \>/= 6 months prior to study entry; 3. Age\>/= 18 years; 4. Routine laboratory studies with bilirubin \</=2 \* upper limits of normal (ULN), aspartate aminotransferase (AST or SGOT) \< 2 \* ULN, creatinine \<1.5 \* ULN, red-cell count \>/= 4,000 per cubic millimeter; white-cell count \>/=1500 per cubic millimeter, platelets \>/= 75,000 per cubic millimeter; PT, APTT, INR in a normal range; 5. Ability to understand and willingness to sign a written informed consent document, or constant caregivers who well understand and willingness to sign a written informed consent document. Exclusion Criteria: 1. Evidence of metastatic disease or tumor recurrence, tumor invasion to major vessels (e.g. the carotid); 2. Evidence of very high intracranial pressure that suggests brain hernia and need surgery; 3. History of seizures or bleeding related to tumor or radiotherapy during or after the completion of radiation; 4. History of coagulation defects or allergy history of contrast agent; 5. History of disorder that affects swallowing, including brain stroke, oral or throat disease, malignances diseases, infection of the nervous system, demyelinating disease, neurodegenerative disease, advanced dementia, diabetes, peripheral vascular disease, HIV infection, familial degenerative peripheral neuropathy; 6. Severe complications: 1) New York heart association grade II or greater congestive heart failure; 2) Serious and inadequately controlled cardiac arrhythmia; 3) Significant vascular disease (e.g. aortic aneurysm, history of aortic dissection); 4) Clinically significant peripheral vascular disease; 5) significant uncontrolled life-threatening infection; 7. Prior use of acupuncture for dysphagia; 8. Enrolled in other clinical trials.
References
Publications (0)
Data not yet available
No reference posted for this study.