Clinical trial · Observational
Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer
NCT01089803CI-TRIAL-00020061completedClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this prospective, multi-institutional, observational cohort study is to determine if an initial surgical approach leads to better function and quality of life than primary chemoradiation in a subset of patients with advanced hypopharyngeal and laryngeal cancers.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Laryngeal Cancer | Malignant Laryngeal Neoplasm | CURATED_EXACT | 0.92 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Patients Treated with Laryngectomy
- description
- Patients initially treated with laryngectomy and followed for 12 months after receiving this treatment.
- label
- Patients Treated with Chemoradiation
- description
- Patients treated initially with chemoradiation and followed for 12 months after receiving treatment.
Primary outcomes (1)
- measure
- Swallowing Function Scores
- timeFrame
- 12 months after Treatment
- description
- The primary outcome will be self-reported swallowing function (M.D. Anderson Dysphagia Inventory questionnaire - MDADI) 12 months after treatment. Analysis will compare MDADI scores of patients treated initially with laryngectomy vs. those of patients treated initially with chemoradiation.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Willingness and ability to complete self-administered follow-up questionnaires over the course of one year as determined by a member of the research team * Voluntary written informed consent with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care * Must be at least 18 years of age Exclusion Criteria: * Require a resection that would involve more than the standard laryngectomy (total pharyngectomy, esophagectomy) * Undergo partial laryngectomy, when open or endoscopic * Have previously altered anatomy of the upper aerodigestive tract * Have pre-existing dysphagia unrelated to the tumor, or neurologic disorders that could affect swallowing (Parkinson's, cerebrovascular accidents) * Have prior malignant disease of the upper aerodigestive tract * Have prior radiation therapy to the head and neck region * Metastatic disease * Unable to complete self-administered questionnaires written in simple English for cognitive, psychiatric, or other reasons that in the opinion of the enrolling investigator is likely to interfere with participation in this clinical study.
References
Publications (0)
Data not yet available
No reference posted for this study.