Home-based treatment program to improve quality of life and swallowing function in head and neck cancer patients with chronic swallowing disorders after treatment with chemoradiotherapy

Not Applicable

• Conditions: Chronic radiation-associated dysphagia in head and neck cancer survivors; Signs and Symptoms; Dysphagia

• Registration Number: ISRCTN57028065
• Lead Sponsor: Antwerp University Hospital

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36273210/ (added 24/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-15
• Last Update Posted: 7 November 2022
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

1. Patients with a history of head and neck cancer treated with radiotherapy or chemoradiotherapy
2. Diagnosis of C-RAD, present for at least 3 months, based on the EAT-10 (score =3) and/or FOIS (max level 6 out of 7)
3. Eligible tumour sites: oral cavity, oropharynx, larynx, hypopharynx and nasopharynx
4. At least 6 months post-treatment

Exclusion Criteria

1. History of major surgery within the head and neck region
2. Recurrent carcinoma in the head and neck region
3. Neurological history that might adversely affect cognition, muscle strength in the head and neck region or swallowing function
4. Dysphagia prior to CRT
5. Intensive swallowing therapy (> once per week) in the last 6 months
6. Complete dependency on tube feeding during more than 1 year
7. Severe frailty or worse following the Clinical Frailty Scale (CFS) (=7)
8. Related to HD-tDCS: presence of implanted metal or electronic medical devices in the brain or other sites in the body (e.g. deep brain stimulator, cochlear Implant, pacemaker) except for dental implants, history of migraine, epilepsy, brain damage (stroke) or head trauma followed by impairment or consciousness, skin problems (e.g. dermatitis, psoriasis) and use of medication that interferes with non-invasive brain stimulation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional oral intake based on scores from the Functional Oral Intake Scale (FOIS) measured after 8 weeks of training