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

NCT03068559 | Completed

• 2 other identifiers: 2012/052012-A01030-43
• Study Type: observational
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

• moderate to severe dysphagia

  DHI questionnaire

  18 months

Secondary Outcomes (6)

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

  18 months

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

  18 months

• time of dysphagia occurrence

  18 months

• length of dysphagia

  18 months

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

  18 months

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with a HNCC beginning a first line treatment

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: March 3, 2017
• Study Start: December 20, 2012
• Primary Completion: December 15, 2014
• Study Completion: September 15, 2016
• Last Updated: September 30, 2025

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share