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DysphagiaDYSPHAGIANCT03068559

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

An observational study of Dysphagia, run by Centre Antoine Lacassagne.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dysphagia
Type of treatment
Pill or oral medicine
How many people
240 participants
Where
No sites listed yet
Study dates
20 Dec 2012to 15 Sep 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patient with a HNCC beginning a first line treatment

Who may be able to join

  • 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).

Who cannot join

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

About this study

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.

Conditions
Dysphagia
Medical subject headings
Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03068559
Study groupRoleWhat they receive
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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. moderate to severe dysphagia

    DHI questionnaire

    Measured: 18 months

Secondary outcomes (6)
  1. frequency of dysphagia reported by investigator using NCI-CTCAE v4.0 grading

    Measured: 18 months

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

    (DHI questionnaire, score ≥16)

    Measured: 18 months

  3. time of dysphagia occurrence

    Measured: 18 months

  4. length of dysphagia

    Measured: 18 months

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

    Measured: 18 months

  6. necessity and total length of Enteral Nutrition

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2017
  2. Study start20 Dec 2012
  3. Primary completion15 Dec 2014
  4. Study completion15 Sep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03068559
Sponsor's protocol ID
2012/05
Other IDs
2012-A01030-43
Acronym
DYSPHAGIA
Status last verified
Mar 2017
First submitted
15 Feb 2017
Last updated
30 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Dysphagia, run by Centre Antoine Lacassagne.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

moderate to severe dysphagia (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.

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