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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02657850




Registration number
NCT02657850
Ethics application status
Date submitted
11/01/2016
Date registered
18/01/2016
Date last updated
18/03/2019

Titles & IDs
Public title
Head and Neck Cancer Treatment Related Dysphagia
Scientific title
Multi-Institution Longitudinal Evaluation of Head and Neck Cancer Treatment - Related Dysphagia
Secondary ID [1] 0 0
IRB00074509
Secondary ID [2] 0 0
J1670
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 0 0
Dysphagia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Head and neck
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - non- head and neck self reporting
Other interventions - head neck self reporting
Other interventions - provider reporting

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.

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

Other interventions: head neck self reporting
head and neck patient self reports dysphagia symptoms

Other interventions: provider reporting
provider reports on head and neck cancer patients' dysphagia symptoms

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
Change in rate of dysphagia between non head and neck and head and neck patients - To compare the 24-month rates of dysphagia (SSQ >234 rate) between head and neck cancer patients and non-head and neck patients.
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
change in dysphagia across different patient treatments - To estimate the treatment specific rate of dysphagia (SSQ >234 rate). Treatment modality by surgery.
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
change in dysphagia across different patient treatments - To estimate the treatment specific rate of surgery with postoperative radiotherapy.
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
change in dysphagia across different patient treatments - To estimate the treatment specific rate of surgery with surgery with postoperative concurrent chemoradiation.
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
change in dysphagia across different patient treatments - To estimate the treatment specific rate of surgery with radiotherapy alone.
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
change in dysphagia across different patient treatments - To estimate the treatment specific rate of surgery with concurrent chemoradiation and induction chemotherapy followed by concurrent chemoradiation.
Timepoint [6] 0 0
24 months
Secondary outcome [7] 0 0
change in rate of secondary treatment side effect - To explore treatment effects on other secondary endpoint: pain visual analog scale
Timepoint [7] 0 0
24 months
Secondary outcome [8] 0 0
change in rate of secondary treatment side effect - To explore treatment effects on other secondary endpoint: speech-language pathology (SLP) recommended swallow exercise adherence status.
Timepoint [8] 0 0
24 months
Secondary outcome [9] 0 0
change in rate of secondary treatment side effect - To explore treatment effects on other secondary endpoint: Functional Oral Intake Scale (FOIS) Diet Level and disease status / pattern of relapse.
Timepoint [9] 0 0
24 months

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of New South Wales - St. George Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
China
State/province [8] 0 0
Hong Kong

Funding & Sponsors
Primary sponsor type
Other
Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02657850
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Harry Quon, M.D.
Address 0 0
The SKCCC at Johns Hopkins
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02657850