Clinical trial · Observational
Head and Neck Cancer Treatment Related Dysphagia
Multi-Institution Longitudinal Evaluation of Head and Neck Cancer Treatment - Related Dysphagia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): study approval lapsed
Summary
Brief summary (as posted)
Cancers located in the upper aerodigestive tract of the head and neck region present unique management challenges due to the crucial functions in this anatomic region along with its anatomic density. As such, cancers themselves and the actual treatment can affect these functions. Of these, the ability to effectively and safely transport a swallow bolus from the oral cavity to the esophagus is particularly important. This consideration has in fact been a major source of debate regarding the optimal management for head and neck cancers as both oncologic-effective and function-preserving therapies are desired. Accomplishing this therapeutic goal has been elusive and can be attributed to a lack of tools that effectively and longitudinally evaluate swallow function over the course of a treatment and in follow-up. As such, investigators surprisingly lack a clear understanding of the natural history of treatment -related swallow dysfunction (dysphagia) regardless of the treatment modality. As such, understanding the prevalence of this significant complication is in fact not well established. Understanding the true prevalence of treatment-related dysphagia is in fact critical to establish as it will help guide decisions as to whether or not treatment strategies require modification including de-intensification of treatment that is receiving considerable attention for favourable prognosis patients associated with the human papillomavirus (HPV). To address this problem, winvestigators hypothesize that the quantitative and validated patient-reported outcome (PRO) instrument, the Sydney Swallow Questionnaire (SSQ), can be an effective tool to longitudinally measure swallow function to determine the natural history of head and neck cancer treatment-related swallow dysphagia. The SSQ is particularly well suited for longitudinal evaluation of swallow function as it quantifies various aspect of patient-perceived swallow function in contrast to other swallow PROs that measure the impact of swallow function on quality of life domains. To determine the two-year prevalence of dysphagia, investigators will employ a multi-institution prospective study design using our Oncospace® web-portal to facilitate secure prospective data curation and analysis that will include evaluations before, during and following standard of care definitive cancer treatment for a total of 36 months in the follow-up period.
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 |
|---|---|---|---|
| Dysphagia | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| head neck self reporting | Other | — | UNRESOLVED |
| non- head and neck self reporting | Other | — | UNRESOLVED |
| provider reporting | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- control cohort - study subject self-reporting
- description
- Participants who have another cancer (not head and neck cancer) and undergoing treatment will self-report their dysphagia symptoms.
- interventionNames
- Other: non- head and neck self reporting
- label
- study cohort - study subject self-reporting
- description
- Participants who have head and neck cancer and undergoing treatment will self-report their dysphagia symptoms.
- interventionNames
- Other: head neck self reporting
- label
- study cohort - provider reporting
- description
- Participants who have head and neck cancer and undergoing treatment will have their dysphagia symptoms reported by the provider.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria - Head and Neck Cancer Study Subjects: 1. Previously untreated head and neck cancer of any histology receiving treatment with curative oncologic intent regardless of the treatment modality. 2. Capable of providing informed consent. Inclusion Criteria - Non-Head and Neck Cancer Study Subjects 1. Previously untreated cancer of any histology with no prior history of swallowing disorder and receiving radiation or concurrent chemoradiation or chemotherapy followed by radiation or concurrent chemoradiation. 2. Screening SSQ \<234 prior to any cancer treatment. 3. Capable of providing informed consent. Exclusion Criteria - 1. Potential study subjects who are unwilling or unable to be adherent to longitudinal assessment and follow-up. This will include potential study subjects who have poor performance status at the time of study enrollment evaluation. 2. Potential study subjects who have cognitive limitations / impairments that prevent a potential study subject's ability to provide self-reporting with the SSQ instrument and/or other data elements required as described in the study calendar. 3. Potential study subjects who have motor skill limitations that prevent a potential study subject's ability to provide self-reporting with the SSQ instrument and/or other data elements required as described in the study calendar.
References
Publications (0)
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