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Head and Neck Cancer Treatment Related Dysphagia

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ClinicalTrials.gov Identifier: NCT02657850
Recruitment Status : Withdrawn (study approval lapsed)
First Posted : January 18, 2016
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief 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.


Condition or disease Intervention/treatment
Head and Neck Cancer Dysphagia Other: non- head and neck self reporting Other: head neck self reporting Other: provider reporting

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-Institution Longitudinal Evaluation of Head and Neck Cancer Treatment - Related Dysphagia
Actual Study Start Date : June 9, 2016
Actual Primary Completion Date : June 8, 2017
Actual Study Completion Date : June 8, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
control cohort - study subject self-reporting
Participants who have another cancer (not head and neck cancer) and undergoing treatment will self-report their dysphagia symptoms.
Other: non- head and neck self reporting
non- head and neck patient self reports dysphagia symptoms

study cohort - study subject self-reporting
Participants who have head and neck cancer and undergoing treatment will self-report their dysphagia symptoms.
Other: head neck self reporting
head and neck patient self reports dysphagia symptoms

study cohort - provider reporting
Participants who have head and neck cancer and undergoing treatment will have their dysphagia symptoms reported by the provider.
Other: provider reporting
provider reports on head and neck cancer patients' dysphagia symptoms




Primary Outcome Measures :
  1. Change in rate of dysphagia symptoms [ Time Frame: 24 months ]
    To estimate the 24-month rate of dysphagia (SSQ >234 rate) as defined by the proportion of patients with total SSQ score greater than 234 at the end of 24 months follow up. This threshold value has previously been validated (1).


Secondary Outcome Measures :
  1. Change in rate of dysphagia between non head and neck and head and neck patients [ Time Frame: 24 months ]
    To compare the 24-month rates of dysphagia (SSQ >234 rate) between head and neck cancer patients and non-head and neck patients.

  2. change in dysphagia across different patient treatments [ Time Frame: 24 months ]
    To estimate the treatment specific rate of dysphagia (SSQ >234 rate). Treatment modality by surgery.

  3. change in dysphagia across different patient treatments [ Time Frame: 24 months ]
    To estimate the treatment specific rate of surgery with postoperative radiotherapy.

  4. change in dysphagia across different patient treatments [ Time Frame: 24 months ]
    To estimate the treatment specific rate of surgery with surgery with postoperative concurrent chemoradiation.

  5. change in dysphagia across different patient treatments [ Time Frame: 24 months ]
    To estimate the treatment specific rate of surgery with radiotherapy alone.

  6. change in dysphagia across different patient treatments [ Time Frame: 24 months ]
    To estimate the treatment specific rate of surgery with concurrent chemoradiation and induction chemotherapy followed by concurrent chemoradiation.

  7. change in rate of secondary treatment side effect [ Time Frame: 24 months ]
    To explore treatment effects on other secondary endpoint: pain visual analog scale

  8. change in rate of secondary treatment side effect [ Time Frame: 24 months ]
    To explore treatment effects on other secondary endpoint: speech-language pathology (SLP) recommended swallow exercise adherence status.

  9. change in rate of secondary treatment side effect [ Time Frame: 24 months ]
    To explore treatment effects on other secondary endpoint: Functional Oral Intake Scale (FOIS) Diet Level and disease status / pattern of relapse.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
head and neck cancer
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657850


Locations
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United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80203
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63130
United States, New York
Lennox Hill Hospital
New York, New York, United States, 10075
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Australia, New South Wales
University of New South Wales - St. George Hospital
Sydney, New South Wales, Australia
Canada, Ontario
University of Toronto - Odette Cancer Center
Toronto, Ontario, Canada
China
University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
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Principal Investigator: Harry Quon, M.D. The SKCCC at Johns Hopkins

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT02657850     History of Changes
Other Study ID Numbers: J1670
IRB00074509 ( Other Identifier: JHM IRB )
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Deglutition Disorders
Neoplasms by Site
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases