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Head and Neck Cancer Treatment Related Dysphagia

NCT02657850 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2019-03-18

No results posted yet for this study

Summary

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

Interventions

OTHER

non- head and neck self reporting

non- head and neck patient self reports dysphagia symptoms

OTHER

head neck self reporting

head and neck patient self reports dysphagia symptoms

OTHER

provider reporting

provider reports on head and neck cancer patients' dysphagia symptoms

Sponsors & Collaborators

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Harry Quon, M.D. · The SKCCC at Johns Hopkins

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-09
Primary Completion
2017-06-08
Completion
2017-06-08

Countries

  • United States
  • Australia
  • Canada
  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02657850 on ClinicalTrials.gov