Dysphagia Clinical Trial
Official title:
Consequences of an Initial Treatment for Head and Neck Cancer on Swallowing Function: Impact on Nutritional Status
The aim of the present prospective study was to assess dysphagia (occurrence, severity,
length) in head and neck cancer (HNC), from diagnosis to 18 months after their first line
treatment regardless of the treatment. The investigators have complied with the pre-listed
clusters.
For this purpose, pursuant to consensus on the dysphagia assessment, the investigators used
the Deglutition Handicap Index (DHI) questionnaire (Silbergleit 2012) for dysphagia
screening and patient's self-perception. This was the only questionnaire validated in French
evaluating the swallowing function by the patient (Woizard 2006).
Clinical evaluation according to NCI-CTCAE v4.0 criteria and objective measures of
swallowing function were also recorded and compared to DHI results.
Swallowing is one of the main functions in which oral, pharyngeal and laryngeal functions
cooperate. Tumors in this area, as well as their treatments, can seriously impair the
swallowing function, inducing dysphagia, a common complication still badly diagnosed.
However, its impact is constant and always negative on the nutritional status, the treatment
feasibility and the patients' quality of life.
Many teams have tried to determine assessment tools, prevalence and dysphagia treatment
strategies. Thus, recently, in 2014, Kraaijenga et al. made a systematic review of the
literature on these topics. Only 19 studies had been selected on the two previous years. Out
of them, 7 were also literature reviews, including Raber-Durlacher's paper listing all
dysphagia publications from 1990 to 2010. In the other 12 selected studies, 9 were
prospective ones but with either a small number of patients or a specific treatment focused
(e.g. Intensity Modulation Radiation Therapy, radiochemotherapy). For the dysphagia
assessment, Kraaijenga et al. concluded that there is a need for simple self-evaluation
scales compared to professional evaluation ones. The recording of some global indicators of
functional status such as weight, dietary changes, nutritional tube dependence, is also
advised. They concluded that patient-reported measures were commonly applied and provided
complementary perspectives.
More recently, in 2015, Schlinder et al. reported a consensus proposition on the management
of swallowing difficulties in head and neck patients treated by radiotherapy, that was
discussed in the 2013 Milan congress. Six clusters of statements about these difficulties
were reached related to: 1 and 2/ the assessment scales: one patient-reported -the MD
Anderson Dysphagia Inventory- and one operator-reported outcome scales -NCI CTCAE criteria;
3/ the risk factors: research of signs and symptoms of dysphagia consequences e.g.
aspiration; 4/ a preventive swallowing dysfunction evaluation (nutritionist and
deglutologist evaluation); 5/ radiotherapic precautions; 6/ Preventive and therapeutic
swallowing exercises.
The aim of the present prospective study was to assess dysphagia (occurrence, severity,
length) in head and neck cancer (HNC), from diagnosis to 18 months after their first line
treatment regardless of the treatment. The investigators have complied with the pre-listed
clusters.
For this purpose, pursuant to consensus on the dysphagia assessment, the investigators used
the Deglutition Handicap Index (DHI) questionnaire (Silbergleit 2012) for dysphagia
screening and patient's self-perception. This was the only questionnaire validated in French
evaluating the swallowing function by the patient.
Clinical evaluation according to NCI-CTCAE v4.0 criteria and objective measures of
swallowing function were also recorded and compared to DHI results.
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