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CompletedNCT03068559DYSPHAGIAUpdated Sep 30, 2025

Consequences of an Initial Treatment for Head and Neck Cancer on Swallowing Function: Impact on Nutritional Status

An observational study in Dysphagia, sponsored by Centre Antoine Lacassagne. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-30.

Sponsored by Centre Antoine Lacassagne · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
240
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Dysphagia

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03

In context

Deglutition Disorders

710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.

This study's enrollment of 240 is above the median of 97 across 207 observational studies indexed under Deglutition Disorders.

Browse Deglutition Disorders studies →

Lead sponsor

Centre Antoine Lacassagne is the lead sponsor of 65 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient with a HNCC beginning a first line treatment

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

Exclusion Criteria:

  • - Patients treated with prior systemic chemotherapy, radiation therapy or surgery on head and neck area
  • Pregnant or breast-feeding women
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
240 participants (actual)
Patient registry
No

Groups and cohorts

  • Study population

    * 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).

06

What researchers measure

Primary outcomes

  1. moderate to severe dysphagia

    DHI questionnaire

    Time frame: 18 months

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

    (DHI questionnaire, score ≥16)

    Time frame: 18 months

  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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03068559
Lead sponsor
Centre Antoine Lacassagne
Responsible party
Sponsor
First posted
Mar 3, 2017
Start date
Dec 20, 2012
Primary completion
Dec 15, 2014
Completion
Sep 15, 2016
Last update
Sep 30, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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