Towards a patient supported, well-tolerated and evidence-based home-based treatment program to improve quality of life and swallowing function in head and neck cancer survivors with chronic radiation-associated dysphagia treated with chemoradiotherapy: a multicentre randomised controlled trial

Antwerp University Hospital0 个研究点目标入组 105 人开始时间: 2021年7月15日最近更新: 2022年11月7日

适应症

试验速览

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

•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

•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

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