Deglutition DisordersNCT04112940
Physiological Flow of Liquids in Head and Neck Cancer Patients: A Pilot Study
An observational study of Deglutition Disorders and Oropharynx Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This study is part of a larger grant, for which the overall goal is to collect measurements of liquid flow through the oropharynx (i.e., mouth and throat) during swallowing. The focus of this study is to evaluate the flow of liquids of varying consistency in the head and neck cancer population. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Deglutition Disorders, Oropharynx Cancer
- What is being tested?
- Starch-based Thickened Liquids and Xanthan-gum Thickened Liquids
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 19 Dec 2016to 30 Mar 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults who have recently completed radiation treatment for oropharynx cancer at the University Health Network, Toronto.
Who may be able to join
- An initial cancer diagnosis of cancer in the base of tongue region of the oropharynx (Tumor staging T2,T3 \& T4; Nodal staging N0 orN1; Human Papilloma Virus + or -).
- Completion of bilateral radiation therapy to the neck 3 months prior to enrollment
- No longer requiring primary enteral feeding for nutrition.
Who cannot join
- Prior history of swallowing, motor speech, gastro#esophageal difficulties, chronic sinusitis or taste disturbance.
- Previous radiation to the head and neck (prior to current illness);
- Previous cancer diagnosis;
- Prior or planned neck dissection;
- Trachestomy in situ;
- Neurological difficulties unrelated to spinal disorder (e.g. Stroke, Parkinson disease, etc).
Show all 12Show fewer
- Cognitive communication difficulties that may hinder ability to participate.
- Current use of mechanical ventilation
- Type 1 Diabetes (due to the requirement to swallow stimuli containing starch based thickeners, which carry a significant carbohydrate load).
- Known allergies to latex, food coloring or dental glue (due to the probability that these items will come into contact with the oral mucosa during data collection).
- Occupational exposure to radiation exceeding 10 mSv in the past 6 months.
- Current pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
This study is part of a larger grant, for which the overall goal is to collect measurements of liquid flow through the oropharynx (i.e., mouth and throat) during swallowing. The focus of this study is to evaluate the flow of liquids of varying consistency in the head and neck cancer population.
Read the detailed description
Thickened liquids are commonly used as an intervention for dysphagia (swallowing impairment). However, the field lacks a clear understanding of how liquids of different consistencies behave during swallowing. In order to improve understanding of the effectiveness of altered liquid consistency for improving dysphagia, the investigators are studying liquid flow through the oropharynx.
This study explores this question in individuals who have undergone radiation treatment for head and neck cancer, specifically located in the oropharynx.
Participants will swallow 20% w/v barium thickened to different consistencies (thin, slightly thick, and mildly thick) using commercially available food thickeners. Swallowing will be observed under videofluoroscopy.
- Conditions
- Deglutition Disorders, Oropharynx Cancer
- Being tested
- Starch-based Thickened Liquids, Xanthan-gum Thickened Liquids
- Keywords
- Swallowing
- Medical subject headings
- Deglutition Disorders, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Starch-based Thickened LiquidsOther
Also called Nestle Resource ThickenUp
Barium will be thickened to slightly, mildly, moderately and extremely thick consistences as defined by the International Dysphagia Diet Standardisation Initiative flow test.
Xanthan-gum Thickened LiquidsOther
Also called Nestle Resource ThickenUp Clear
Barium will be thickened to slightly, mildly, moderately and extremely thick consistences as defined by the International Dysphagia Diet Standardisation Initiative flow test.
| Study group | Role | What they receive |
|---|---|---|
| Adults with oropharyngeal cancer | Adult participants who have completed radiation therapy for oropharyngeal cancer within the past 3 months will undergo a swallowing x-ray study in which they will swallow up to 15 liquid stimuli prepared to different consistencies using starch and gum based thickeners. Receives: Other: Starch-based Thickened Liquids; Other: Xanthan-gum Thickened Liquids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Unsafe Swallowing
Swallowing safety was measured using the Penetration-Aspiration Scale, an 8-point categorical scale which captures the depth to which any material enters the airway and whether or not the material is ejected. Levels 1 and 2 on the scale are considered safe, while levels > 2 are considered unsafe. Actual scale scores (1-8) will be recorded and then converted to binary categorical scores (< 3 vs >/= 3). We will report the frequency (count) of participants showing scores > 2 by bolus consistency.
Measured: Baseline (single timepoint only)
Amount of Residue in the Pharynx
Residue is material remaining behind in the pharynx after the swallow. We measured residue by tracing the area of barium visible on a lateral view x-ray (in pixels, using ImageJ software) and dividing that area by the squared length C2-C4 cervical spine. This cervical spine scalar provides a common anatomical reference that is a proxy for pharyngeal size, and enables the comparison of residue severity across different people with different neck length and pharynx size. In healthy swallowing, residue is expected to be minimal. We report mean values and standard deviations for amount of residue by consistency (thin, slightly thick, and mildly thick liquids).
Measured: Baseline (single timepoint only)
Secondary outcomes (1)
Number of Participants Reporting Dislike of Thickened Liquid Stimuli
Participants rated the palatability of lemon flavored water and liquid barium stimuli in slightly thick, mildly thick and moderately thick consistencies. Palatability was scored using a 9-point hedonic categorical rating system previously described by Pelletier et al. The ratings use 9 descriptors to capture the degree to which a participant likes a stimulus, with anchors of "Dislike extremely" and "Like extremely". Scores of 1-4 indicate liking of a stimulus, a score of 5 is neutral while scores of 6-9 indicate dislike. We dichotomized this scale between scores of 1-4 (liking) and scores of 5-9 and report the number of participants reporting scores of 6-9 (dislike).
Measured: Baseline (single timepoint only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start19 Dec 2016
- Primary completion31 Dec 2019
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Deglutition DisordersStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Catriona Steele, PhD, Principal investigator, KITE - Toronto Rehabilitation Institute, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112940
- Sponsor's protocol ID
- 16-5190
- Other IDs
- 5R01DC011020, CAPCR 16-5190 (NIH_HNC)
- Status last verified
- Apr 2023
- First submitted
- 27 Sep 2019
- Last updated
- 7 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan at this time.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Flow of Liquids in Head and Neck Cancer Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT04112940
- Acronym / sponsor ID
- 16-5190
- Conditions
- Deglutition Disorders, Oropharynx Cancer
- Keywords
- Swallowing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 19 Dec 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Posted 13 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is part of a larger grant, for which the overall goal is to collect measurements of liquid flow through the oropharynx (i.e., mouth and throat) during swallowing. The focus of this study is to evaluate the flow of liquids of varying consistency in the head and neck cancer population.
Detailed description
Thickened liquids are commonly used as an intervention for dysphagia (swallowing impairment). However, the field lacks a clear understanding of how liquids of different consistencies behave during swallowing. In order to improve understanding of the effectiveness of altered liquid consistency for improving dysphagia, the investigators are studying liquid flow through the oropharynx.
This study explores this question in individuals who have undergone radiation treatment for head and neck cancer, specifically located in the oropharynx.
Participants will swallow 20% w/v barium thickened to different consistencies (thin, slightly thick, and mildly thick) using commercially available food thickeners. Swallowing will be observed under videofluoroscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with oropharyngeal cancer | – | Other: Starch-based Thickened Liquids, Other: Xanthan-gum Thickened LiquidsAdult participants who have completed radiation therapy for oropharyngeal cancer within the past 3 months will undergo a swallowing x-ray study in which they will swallow up to 15 liquid stimuli prepared to different consistencies using starch and gum based thickeners. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who have recently completed radiation treatment for oropharynx cancer at the University Health Network, Toronto.
Key inclusion criteria (3 listed)
- An initial cancer diagnosis of cancer in the base of tongue region of the oropharynx (Tumor staging T2,T3 \& T4; Nodal staging N0 orN1; Human Papilloma Virus + or -).
- Completion of bilateral radiation therapy to the neck 3 months prior to enrollment
- No longer requiring primary enteral feeding for nutrition.
Key exclusion criteria (12 listed)
- Prior history of swallowing, motor speech, gastro#esophageal difficulties, chronic sinusitis or taste disturbance.
- Previous radiation to the head and neck (prior to current illness);
- Previous cancer diagnosis;
- Prior or planned neck dissection;
- Trachestomy in situ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Starch-based Thickened LiquidsAlso: Nestle Resource ThickenUpBarium will be thickened to slightly, mildly, moderately and extremely thick consistences as defined by the International Dysphagia Diet Standardisation Initiative flow test. | Other | Adults with oropharyngeal cancer |
| Xanthan-gum Thickened LiquidsAlso: Nestle Resource ThickenUp ClearBarium will be thickened to slightly, mildly, moderately and extremely thick consistences as defined by the International Dysphagia Diet Standardisation Initiative flow test. | Other | Adults with oropharyngeal cancer |
Primary outcome
Number of Participants With Unsafe Swallowing
Time frame: Baseline (single timepoint only)
Swallowing safety was measured using the Penetration-Aspiration Scale, an 8-point categorical scale which captures the depth to which any material enters the airway and whether or not the material is ejected. Levels 1 and 2 on the scale are considered safe, while levels > 2 are considered unsafe. Actual scale scores (1-8) will be recorded and then converted to binary categorical scores (< 3 vs >/= 3). We will report the frequency (count) of participants showing scores > 2 by bolus consistency.
Amount of Residue in the Pharynx
Time frame: Baseline (single timepoint only)
Residue is material remaining behind in the pharynx after the swallow. We measured residue by tracing the area of barium visible on a lateral view x-ray (in pixels, using ImageJ software) and dividing that area by the squared length C2-C4 cervical spine. This cervical spine scalar provides a common anatomical reference that is a proxy for pharyngeal size, and enables the comparison of residue severity across different people with different neck length and pharynx size. In healthy swallowing, residue is expected to be minimal. We report mean values and standard deviations for amount of residue by consistency (thin, slightly thick, and mildly thick liquids).
1 secondary outcome
Number of Participants Reporting Dislike of Thickened Liquid Stimuli
Time frame: Baseline (single timepoint only)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No plan at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catriona Steele, PhD principal investigator
KITE - Toronto Rehabilitation Institute, University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deglutition Disorders and Oropharynx Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Unsafe Swallowing (time frame: Baseline (single timepoint only)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.