Clinical trial · Interventional
A Pilot Study of ALTENS in Improving Dysphagia Induced by IMRT for Head and Neck Cancers
Effectiveness of Acupuncture-like Transcutaneous Nerve Stimulation (ALTENS) in Improving Dysphagia and Associated Symptoms of Chemotherapy and/or Intensity Modulated Radiation Therapy (IMRT) for Head and Neck Cancers: A Pilot Study
- 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)
Study hypothesis: ALTENS techniques, administered within the first 3 months after radiation completion, can improve radiation-induced dysphagia and associated symptoms in head and neck cancer patients. This beneficial effect is mediated by the reduction of chronic inflammatory response of swallowing musculature to radiation, consequently a reduction in muscle fibrosis. Primary study objective: To evaluate the effectiveness of ALTENS in relieving radiation-induced dysphagia. Eating Assessment Tool (EAT-10) scores will be used for this primary study endpoint.
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 |
|---|---|---|---|
| Dysphagia | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Codetron ALTENS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ALTENS
- description
- Patients in this arm will be treated with Acupuncture-like Transcutaneous Electrical Nerve Stimulation using Codetron (Codetron ALTENS)
- interventionNames
- Device: Codetron ALTENS
Primary outcomes (1)
- measure
- Change in Subjective Dysphagia Assessment Score: EAT-10 from baseline
- timeFrame
- 3 months after treatment completion
- description
- EAT-10 is a self-administered questionnaire for subjective assessment of dysphagia. It consists of 10 items and each item is scored using a 5-point Likert scale. The higher the point, the more severe the problem being scored. Normative data suggested that a total score of 3 or higher is abnormal.
Secondary outcomes (1)
- measure
- Change in M. D. Anderson dysphagia inventory from baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:This study will recruit patients with head and neck cancers treated with radiation+/- chemotherapy and who meet the following criteria (EAT-10 assessment will be used for screening): Inclusion Criteria 1. present with dysphagia symptoms 2. with no evidence of residue cancer 3. are within 3 months (but past 1 month) after treatment completion 4. show positive dysphagia (EAT-10 score of \> 3) and/ or aspiration on barium swallow study 5. are over 18 years old 6. are able to read and write fluent English 7. can give informed consent Exclusion Criteria: 1. have unstable heart disease 2. have infectious disease transmissible by blood or body fluid, including hepatitis and HIV 3. have skin disease at site of study acupuncture points that prevents the application of electrodes
References
Publications (0)
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