Head and Neck Cancer Treatment Related Dysphagia

NCT02657850 | Withdrawn DMC

• 2 other identifiers: J1670IRB00074509
• Study Type: observational
• Target: N/A
• Locations: 4 countries
• Sites: 9

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.

Conditions

Head and Neck Cancer; Dysphagia

Outcome Measures

Primary Outcomes (1)

• Change in rate of dysphagia symptoms

  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).

  24 months

Secondary Outcomes (9)

• Change in rate of dysphagia between non head and neck and head and neck patients

  24 months

• change in dysphagia across different patient treatments

  24 months

• change in dysphagia across different patient treatments

  24 months

• change in dysphagia across different patient treatments

  24 months

• change in dysphagia across different patient treatments

  24 months

Study Arms (3)

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

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

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

Interventions

non- head and neck self reporting OTHER

non- head and neck patient self reports dysphagia symptoms

control cohort - study subject self-reporting

head neck self reporting OTHER

head and neck patient self reports dysphagia symptoms

study cohort - study subject self-reporting

provider reporting OTHER

provider reports on head and neck cancer patients' dysphagia symptoms

study cohort - provider reporting

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

head and neck cancer

You may qualify if:

• Previously untreated head and neck cancer of any histology receiving treatment with curative oncologic intent regardless of the treatment modality.
• Capable of providing informed consent.
• 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.
• Screening SSQ \<234 prior to any cancer treatment.
• Capable of providing informed consent.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (9)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

University of Colorado

Aurora, Colorado, 80203, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University

St Louis, Missouri, 63130, United States

Location

Lennox Hill Hospital

New York, New York, 10075, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

University of New South Wales - St. George Hospital

Sydney, New South Wales, Australia

Location

University of Toronto - Odette Cancer Center

Toronto, Ontario, Canada

Location

University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Deglutition Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Harry Quon, M.D.

  The SKCCC at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 18, 2016
• Study Start: June 9, 2016
• Primary Completion: June 8, 2017
• Study Completion: June 8, 2017
• Last Updated: March 18, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1); US (6); AU (1); CA (1)