Clinical trial · Observational
Consequences of an Initial Treatment for Head and Neck Cancer on Swallowing Function: Impact on Nutritional Status
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dysphagia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Study population
- description
- * 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).
Primary outcomes (1)
- measure
- moderate to severe dysphagia
- timeFrame
- 18 months
- description
- DHI questionnaire
Secondary outcomes (6)
- measure
- frequency of dysphagia reported by investigator using NCI-CTCAE v4.0 grading
- timeFrame
- 18 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available