Head and Neck CancerNCT03435471
Outcomes of Prophylactic Swallowing Therapy in Patients Undergoing Definitive Chemoradiation for Head and Neck Cancer
A study testing Prophylactic Swallowing Home Exercise Program and Clinician-Directed Prophylactic Swallowing Exercises in people with Head and Neck Cancer and Oropharynx Cancer, run by University of Miami at 1 site in United States.
Trial summary
Clinician directed prophylactic swallowing therapy will improve immediate (four weeks +/- two weeks) and short-term (26 weeks +/- four weeks) post-treatment swallowing function and quality of life versus patient directed home exercises. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Oropharynx Cancer
- What is being tested?
- Prophylactic Swallowing Home Exercise Program and Clinician-Directed Prophylactic Swallowing Exercises
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2018to 13 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of head and neck cancer (sites: oropharynx: human papillomavirus (HPV) related and non HPV related tonsil and base of tongue)
- Scheduled to undergo definitive chemoradiation therapy
- At least 18 years of age or older
- Subject must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Surgical management in addition to chemoradiation therapy;
- Cancer of the sinus, brain, or parotid;
- Prior treatment for head and neck cancer;
- Receiving chemoradiation treatment at an outside institution (i.e., non-University of Miami (UM) clinic);
- Prior history of dysphagia unrelated to the current diagnosis of head and neck cancer;
- Prior neurologic disorder (i.e., Cerebrovascular accident (CVA), Traumatic brain injury (TBI), dementia) or current degenerative neuromuscular disease;
- History of prior c-spine surgery;
- History of prior vocal fold immobility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Use of Clinician Directed Prophylactic Swallowing Therapy in Patients Undergoing Definitive Chemoradiation for Head and Neck Cancer Improve Swallowing Function Outcomes?
Clinician directed prophylactic swallowing therapy will improve immediate (four weeks +/- two weeks) and short-term (26 weeks +/- four weeks) post-treatment swallowing function and quality of life versus patient directed home exercises.
The purpose of this prospective, interventional, pilot investigation is to determine whether clinician directed swallowing therapy will improve patient swallowing function outcomes and quality of life in the immediate and short-term basis compared to patients receiving standard of care patient directed independent home swallowing therapy. Patient compliance with home exercises programs is reportedly inconsistent. Patients may experience changes in their physical functioning and overall well-being that may impact their ability to follow-through with independent home therapy. Clinician directed swallowing therapy allows for ongoing assessment of changes that may warrant modifying the therapy program in terms of intensity of exercises and/or expectations. This facilitates individualizing the patient's therapy plan to maximize their function and ability to achieve goals. It is anticipated that individualizing swallowing therapy through weekly session will result in improved swallowing function.
Read the detailed description
This is a single-site, two-arm, 1:1 randomized, prospective, interventional, pilot study to determine whether clinician directed swallowing therapy will improve patient swallowing function outcomes when compared to patient-directed home-based swallowing therapy.
The investigators anticipate at least 40 subjects will need to be enrolled/consented in order to obtain the accrual goal of 15 evaluable subjects for each group for a total of 30 participants.
All subjects in each group will receive a face-to-face education session with a speech pathologist to review a recommended program of swallowing exercises prior to initiation of chemoradiation at their baseline (pre-treatment evaluation session).
- Conditions
- Head and Neck Cancer, Oropharynx Cancer
- Being tested
- Prophylactic Swallowing Home Exercise Program, Clinician-Directed Prophylactic Swallowing Exercises
- Keywords
- Prophylactic Swallowing Therapy
- Medical subject headings
- Head and Neck Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic Swallowing Home Exercise ProgramOther
The home exercise program will consist of six exercises that are recommended to be practiced three times per day. Subjects will complete a weekly exercise log to track compliance.
Clinician-Directed Prophylactic Swallowing ExercisesOther
Once weekly face-to-face meetings with a study speech pathologist for a total of six sessions, to participate in active swallowing exercises
| Study group | Role | What they receive |
|---|---|---|
| G1 - Clinician-Directed Therapy | Experimental | Clinician-Directed Weekly Swallowing Therapy: Once weekly face-to-face meetings with a study speech pathologist for a total of six sessions, to participate in active swallowing exercises and review the home swallowing exercise program. Each session will last 30 minutes +/- ten minutes. Other assessments include:
* Clinician-Directed Prophylactic Swallowing Exercises
* Prophylactic Swallowing Home Exercise Program
* Penetration/Aspiration Scale (PAS)
* Functional Oral Intake Scale (FOIS)
* Eating Assessment Tool-10 (EAT-10)
* University of Washington Quality of Life (UW-QOL)
* Performance Status Scale for Head and Neck Cancer Patients (PSS-HN)
* DIGEST Safety Grade Receives: Other: Prophylactic Swallowing Home Exercise Program; Other: Clinician-Directed Prophylactic Swallowing Exercises |
| G2 - Patient-Directed Home Therapy | Active comparator | Patient-Directed Home Swallowing Therapy: One face-to-face meeting with a study speech pathologist prior to initiation of treatment. During that session, they will be encouraged to practice the given exercises independently on a specific daily schedule regime throughout their treatment. Other assessments include:
* Prophylactic Swallowing Home Exercise Program
* Penetration/Aspiration Scale (PAS)
* Functional Oral Intake Scale (FOIS)
* Eating Assessment Tool-10 (EAT-10)
* University of Washington Quality of Life (UW-QOL)
* Performance Status Scale for Head and Neck Cancer Patients (PSS-HN)
* DIGEST Safety Grade Receives: Other: Prophylactic Swallowing Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in swallowing status
Swallowing status will be measured using Functional Oral Intake Scale (FOIS). FOIS has a range from 0 (most restrictive) to 7 (least restrictive).
Measured: Baseline, Up to 6 weeks
Secondary outcomes (6)
Change in swallowing status as measured by FOIS
FOIS has a range from 0 (most restrictive) to 7 (least restrictive).
Measured: Baseline, Up to 30 weeks
Change in quality of life as measured by PSS-HN
Performance Status Scale - Head and Neck (PSS-HSN) is a questionnaire with a total score ranging from 100 (normal function) to 0 (limited function).
Measured: Baseline to 6 weeks, Baseline to 30 weeks
Change in quality of life as measured by EAT-10
Eating Assessment Tool-10 (EAT-10) is a questionnaire with a total score ranging from 0 to 40 with the lower score indicating better function.
Measured: Baseline to 6 weeks, Baseline to 30 weeks
Change in quality of life as measured by UW-QOL
University of Washington Quality of Life (UW-QOL) is a questionnaire with a total score ranging from 0 to 100 with the higher score indicating poorer health outcomes.
Measured: Baseline to 6 weeks, Baseline to 30 weeks
Proportion of patients requiring further swallowing therapy
Proportion of patients requiring further swallowing therapy post study intervention as per treating physician discretion
Measured: Baseline to 6 weeks, Baseline to 30 weeks
Change in Pharyngeal Swallowing Efficiency and Safety as measured by DIGEST Safety Grade
DIGEST is a measure of pharyngeal swallowing efficiency and safety. The DIGEST measure incorporates 2 measures:
- Safety as determined by the Penetration Aspiration Scale with a score ranging from 0 (safe) to 4 (life-threatening unsafe); and
- Efficiency as determined by the quantity of residue observed on the videoflouroscopic swallowing study with a score ranging from 0 (efficient) to 4 (life-threatening inefficiency).
These two measures combine for an overall score, ranging from 0 (no pharyngeal dysphagia) to 4 (life-threatening dysphagia).
Measured: Baseline to 6 weeks, Baseline to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start17 Sep 2018
- Primary completion17 Jul 2020
- Study completion13 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donna S. Lundy, University of Miami
- Investigators
- Donna S Lundy, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435471
- Sponsor's protocol ID
- 20180084
- Status last verified
- Jan 2021
- First submitted
- 9 Feb 2018
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Use of Clinician Directed Prophylactic Swallowing Therapy in Patients Undergoing Definitive Chemoradiation for Head and Neck Cancer Improve Swallowing Function Outcomes?
- ClinicalTrials.gov ID
- NCT03435471
- Acronym / sponsor ID
- 20180084
- Conditions
- Head and Neck Cancer, Oropharynx Cancer
- Keywords
- Prophylactic Swallowing Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 17 Jul 2020 (actual)
- Study completion
- 13 Jan 2021 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinician directed prophylactic swallowing therapy will improve immediate (four weeks +/- two weeks) and short-term (26 weeks +/- four weeks) post-treatment swallowing function and quality of life versus patient directed home exercises.
The purpose of this prospective, interventional, pilot investigation is to determine whether clinician directed swallowing therapy will improve patient swallowing function outcomes and quality of life in the immediate and short-term basis compared to patients receiving standard of care patient directed independent home swallowing therapy. Patient compliance with home exercises programs is reportedly inconsistent. Patients may experience changes in their physical functioning and overall well-being that may impact their ability to follow-through with independent home therapy. Clinician directed swallowing therapy allows for ongoing assessment of changes that may warrant modifying the therapy program in terms of intensity of exercises and/or expectations. This facilitates individualizing the patient's therapy plan to maximize their function and ability to achieve goals. It is anticipated that individualizing swallowing therapy through weekly session will result in improved swallowing function.
Detailed description
This is a single-site, two-arm, 1:1 randomized, prospective, interventional, pilot study to determine whether clinician directed swallowing therapy will improve patient swallowing function outcomes when compared to patient-directed home-based swallowing therapy.
The investigators anticipate at least 40 subjects will need to be enrolled/consented in order to obtain the accrual goal of 15 evaluable subjects for each group for a total of 30 participants.
All subjects in each group will receive a face-to-face education session with a speech pathologist to review a recommended program of swallowing exercises prior to initiation of chemoradiation at their baseline (pre-treatment evaluation session).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G1 - Clinician-Directed Therapy | Experimental | Other: Prophylactic Swallowing Home Exercise Program, Other: Clinician-Directed Prophylactic Swallowing ExercisesClinician-Directed Weekly Swallowing Therapy: Once weekly face-to-face meetings with a study speech pathologist for a total of six sessions, to participate in active swallowing exercises and review the home swallowing exercise program. Each session will last 30 minutes +/- ten minutes. Other assessments include: * Clinician-Directed Prophylactic Swallowing Exercises * Prophylactic Swallowing Home Exercise Program * Penetration/Aspiration Scale (PAS) * Functional Oral Intake Scale (FOIS) * Eating Assessment Tool-10 (EAT-10) * University of Washington Quality of Life (UW-QOL) * Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) * DIGEST Safety Grade |
| G2 - Patient-Directed Home Therapy | Active comparator | Other: Prophylactic Swallowing Home Exercise ProgramPatient-Directed Home Swallowing Therapy: One face-to-face meeting with a study speech pathologist prior to initiation of treatment. During that session, they will be encouraged to practice the given exercises independently on a specific daily schedule regime throughout their treatment. Other assessments include: * Prophylactic Swallowing Home Exercise Program * Penetration/Aspiration Scale (PAS) * Functional Oral Intake Scale (FOIS) * Eating Assessment Tool-10 (EAT-10) * University of Washington Quality of Life (UW-QOL) * Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) * DIGEST Safety Grade |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of head and neck cancer (sites: oropharynx: human papillomavirus (HPV) related and non HPV related tonsil and base of tongue)
- Scheduled to undergo definitive chemoradiation therapy
- At least 18 years of age or older
- Subject must have the ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (8 listed)
- Surgical management in addition to chemoradiation therapy;
- Cancer of the sinus, brain, or parotid;
- Prior treatment for head and neck cancer;
- Receiving chemoradiation treatment at an outside institution (i.e., non-University of Miami (UM) clinic);
- Prior history of dysphagia unrelated to the current diagnosis of head and neck cancer;
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 |
|---|---|---|
| Prophylactic Swallowing Home Exercise ProgramThe home exercise program will consist of six exercises that are recommended to be practiced three times per day. Subjects will complete a weekly exercise log to track compliance. | Other | G1 - Clinician-Directed Therapy, G2 - Patient-Directed Home Therapy |
| Clinician-Directed Prophylactic Swallowing ExercisesOnce weekly face-to-face meetings with a study speech pathologist for a total of six sessions, to participate in active swallowing exercises | Other | G1 - Clinician-Directed Therapy |
Primary outcome
Change in swallowing status
Time frame: Baseline, Up to 6 weeks
Swallowing status will be measured using Functional Oral Intake Scale (FOIS). FOIS has a range from 0 (most restrictive) to 7 (least restrictive).
6 secondary outcomes
Change in swallowing status as measured by FOIS
Time frame: Baseline, Up to 30 weeks
Change in quality of life as measured by PSS-HN
Time frame: Baseline to 6 weeks, Baseline to 30 weeks
Change in quality of life as measured by EAT-10
Time frame: Baseline to 6 weeks, Baseline to 30 weeks
Change in quality of life as measured by UW-QOL
Time frame: Baseline to 6 weeks, Baseline to 30 weeks
Proportion of patients requiring further swallowing therapy
Time frame: Baseline to 6 weeks, Baseline to 30 weeks
Change in Pharyngeal Swallowing Efficiency and Safety as measured by DIGEST Safety Grade
Time frame: Baseline to 6 weeks, Baseline to 30 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Donna S Lundy, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic Swallowing Home Exercise Program and Clinician-Directed Prophylactic Swallowing Exercises in people with Head and Neck Cancer and Oropharynx Cancer, run by University of Miami at 1 site in United States.
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 4 inclusion and 8 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 27 Jan 2021. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in swallowing status (time frame: Baseline, Up to 6 weeks). 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 27 Jan 2021.