A Pilot Study of ALTENS in Improving Dysphagia Induced by IMRT for Head and Neck Cancers

McMaster University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Dysphagia; Head and Neck Cancer

Treatments: Device: Codetron ALTENS

Study type: Interventional

Funder types: Other

Identifiers

NCT01697891

MU12-530

Details and patient eligibility

About

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.

Full description

Difficulty in swallowing is a concerning symptom after radiation treatment for some types of head and neck cancers. Swallowing becomes difficult when radiation damage induces inflammation (with swelling and pain) in the inner covering tissues of the throat and muscles that involve in the swallowing process. Currently, supportive measures are used to manage this symptom while waiting for the tissue damages to heal. In some patients, the inflamed muscles develop scar tissues causing long-term swallowing difficulty and narrowing of the swallowing passage. Needle acupuncture may help to reduce tissue inflammation and may lessen the severity of swallowing difficulty. However, needle puncture is often not desired by patients. Acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) is like acupuncture treatment, but the acupuncture points are stimulated with mild electrical stimulation without needles, simplifying treatment delivery. This study is to examine if a pre-selected set of acupuncture points treated using ALTENS can reduce swallowing difficulty. There will be a total of 12 treatments given over 6 to 8 weeks. Changes in severity of swallowing difficult after treatment will be assessed using 2 subjective assessment tools.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

ALTENS

Experimental group

Description:

Patients in this arm will be treated with Acupuncture-like Transcutaneous Electrical Nerve Stimulation using Codetron (Codetron ALTENS)

Treatment:

Device: Codetron ALTENS