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Completed

NCT Number: NCT03068559

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient must have an initial confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx.
  • Patient has to be aged ≥ 18
  • Patient has to be able to complete questionnaire in French
  • Patient must benefit from health insurance
  • Patient must sign an informed consent form
  • Patient treatment must be validated in a medical multidisciplinary team meeting: surgery, radiotherapy (RT), chemotherapy (CT), radiochemotherapy (RTCT), induction chemotherapy followed by radiochemotherapy (IND+RTCT), surgery followed by radiotherapy (surgery+RT), surgery followed by radiochemotherapy (surgery+RTCT).

Exclusion criteria

  • - Patients treated with prior systemic chemotherapy, radiation therapy or surgery on head and neck area
  • Pregnant or breast-feeding women

Treatment and study plan

Primary outcomes

  1. moderate to severe dysphagia

    Time frame: 18 months

    DHI questionnaire

Secondary outcomes

  1. frequency of dysphagia reported by investigator using NCI-CTCAE v4.0 grading

    Time frame: 18 months

  2. comparison of grade 2 to 4 clinical dysphagia and self-perceived moderate/severe dysphagia

    Time frame: 18 months

    (DHI questionnaire, score ≥16)

  3. time of dysphagia occurrence

    Time frame: 18 months

  4. length of dysphagia

    Time frame: 18 months

  5. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 18 months

  6. necessity and total length of Enteral Nutrition

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Centre Antoine Lacassagne

Other

Registry information

Acronym: DYSPHAGIA

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Mar 3, 2017
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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