Dysphagia Clinical Trial
— DYSPHAGIAOfficial title:
Consequences of an Initial Treatment for Head and Neck Cancer on Swallowing Function: Impact on Nutritional Status
Verified date | March 2017 |
Source | Centre Antoine Lacassagne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 240 |
Est. completion date | September 15, 2016 |
Est. primary completion date | December 15, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Centre Antoine Lacassagne |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | moderate to severe dysphagia | DHI questionnaire | 18 months | |
Secondary | frequency of dysphagia reported by investigator using NCI-CTCAE v4.0 grading | 18 months | ||
Secondary | comparison of grade 2 to 4 clinical dysphagia and self-perceived moderate/severe dysphagia | (DHI questionnaire, score =16) | 18 months | |
Secondary | time of dysphagia occurrence | 18 months | ||
Secondary | length of dysphagia | 18 months | ||
Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 18 months | ||
Secondary | necessity and total length of Enteral Nutrition | 18 months |
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