Oral Cavity Squamous Cell CarcinomaBiofeedbackNCT03650699
Biofeedback Rehabilitation to Improve Speaking and Eating in Public
A study testing Electropalatography Biofeedback Training in people with Oral Cavity Squamous Cell Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Tongue cancer requires resection and reconstruction that can leave patients disabled with respect to speaking and eating. Impairment of tongue function can have significant impact on social interaction and employment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Cavity Squamous Cell Carcinoma
- What is being tested?
- Electropalatography Biofeedback Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 28 Sep 2018to 1 Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Oral cavity carcinoma involving the tongue or floor of the mouth
- Primary surgical treatment or/
- Primary surgical treatment with adjuvant radiation therapy or/
- Salvage surgical treatment
- At least 2 weeks post treatment
Who cannot join
- Anatomic palate abnormality that precludes fitting a mouthpiece
- Cognitively unable to participate in biofeedback
- Persistent Cancer
- Does not speak English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rehabilitation of Head and Neck Cancer Patients With Biofeedback Training to Improve Speaking and Eating in Public
Tongue cancer requires resection and reconstruction that can leave patients disabled with respect to speaking and eating. Impairment of tongue function can have significant impact on social interaction and employment. To try and improve speaking and eating in public, the team at the University Health Network is going to use a special device that is designed to help the patient rehabilitate after tongue cancer treatment.
The research part of this study is to use a special mouthpiece or mold that is like a partial plate for upper dentures that will fit on the roof of the mouth. This mold is embedded with 62 sensors that will allow patients to visualize their tongue position during speech. With the help of a speech therapist, patients can learn different tongue positions important speaking and eating. This whole process is called biofeedback. The visualization of the tongue gives the patient the flexibility to practice at home to and learn different tongue positions important to eating and speaking. In addition, the device will provide the speech pathologist with an opportunity for easier and more precise assessment of the patient's progress which can reduce the need for visits to the hospital. The investigators expect the biofeedback training to improve the patient's speaking and eating.
The study hypothesis is that the biofeedback device will improve speech intelligibility, eating in public, speaking in public, and oral intake scores.
Read the detailed description
Subjects will be enrolled in either arm of the study for duration of 4 months. Patients that are randomized into study arm 1 will come to the clinic for Speech Language Pathologist (SLP) directed face-to-face rehabilitation for a period of 2 months. The patients will then transition to participate in weekly face-to-face Electropalatography (EPG) biofeedback training. The EPG biofeedback will be used for 2 months. Patients that are randomized into study arm 2 will first undergo a self-directed tongue strengthening program (oral exercises) for a period of 2 months and then transition into EPG biofeedback training.
Although randomization will be used, this is a nonstandard trial because all patients will receive biofeedback EPG. Patients from both study arms will receive biofeedback training after undergoing an SLP directed face-to-face rehabilitation program versus a self-directed tongue strengthening program (oral exercises). The SLP directed face-to-face rehabilitation program or self-directed tongue strengthening program will be initiated at least 2 weeks post-surgery. If the patient is treated with adjuvant radiation, the patient will take a self-directed biofeedback holiday with a target of restarting at least 2 after the completion of adjuvant treatment.
This design was chosen because there is equipoise with respect to the efficacy of the intervention and uncertainty with respect to whether the intervention is most valuable following an SLP directed face-to-face rehabilitation program versus a self-directed tongue strengthening program. The design offers all patients the opportunity to participate in the intervention. This approach will also allow us to analyze between subject change and within subject change.
The A.I.D.S assessment has been in place for approximately 50 years. The mean A.I.D.S. efficiency score (95%CI) in the current pilot study (n=16) is 0.54 (46.0, 62.3). With 33 patients in each group, there will be over 80% power to detect a 10% difference in the speech efficiency score even under the condition that there may be low (rho<0.1) correlation within subject. Higher correlation within subject on the various scores would serve to increase the efficiency of the analysis.
Bivariate comparison will be made between the arms with respect to the primary and secondary outcome variables at each time point.
Linear mixed model will be used to account for multiple measures at multiple time points. The first step will be to compare arms with respect to the primary and secondary outcome variables. For those tests that are significant a backward selected regression will be performed to control for confounders and to look for important effect modifier variables. Variables related to rehabilitation participation will be modeled in the backward selected regression.
- Conditions
- Oral Cavity Squamous Cell Carcinoma
- Being tested
- Electropalatography Biofeedback Training
- Keywords
- Oral Cavity Squamous Cell Carcinoma, Biofeedback, Rehabilitation, Head and Neck Cancer, electropalatography, EPG
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electropalatography Biofeedback TrainingDevice
The study agent is electropalatography (EPG). The LinguaGraph EPG device is a biofeedback technology that creates a digital visualization of tongue function during speech. The visualization is accomplished by a custom made mouthpiece that fits over the hard palate with 62 sensors that capture tongue position. The information from the sensors in the mouthpiece, as well as the audio output, is processed in an EPG Unit that converts the information from mouthpiece to a visual representation on a computer screen. The visual information with respect to tongue position can be used to provide biofeedback training.The computer can be used in the clinic during a patient visit or it can be seen over the internet with the patient at home and the speech and language pathologist at the clinic.
| Study group | Role | What they receive |
|---|---|---|
| Self-Directed Tongue Strengthening Rehab | Experimental | 8 sessions of self-directed tongue strengthening exercises followed by 8 sessions of electropalatography biofeedback training.
Assessments will be taken during the beginning, middle, and end of each study arm. Receives: Device: Electropalatography Biofeedback Training |
| SLP Directed Face-to-Face Rehab | Experimental | 8 sessions of SLP-directed face-to-face rehabilitation program followed by 8 sessions of electropalatography biofeedback training.
Assessments will be taken during the beginning, middle, and end of each study arm. Receives: Device: Electropalatography Biofeedback Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percent Intelligibility of Speech Over 4 Months
Change in percent intelligibility is measured using Assessment of Intelligibility of Dysarthric Speech (AIDS). Assessment of Intelligibility of Dysarthric Speech (AIDS) is a validated tool that is used in this outcome to measure intelligibility as compared with normal subjects for quantifying single-word intelligibility and sentence intelligibility.
Measured: Administered at 0, 2, and 4 months
Change in Rate of Intelligible Speech Over 4 Months
Change in intelligibility rate is also measured using Assessment of Intelligibility of Dysarthric Speech (AIDS). Assessment of Intelligibility of Dysarthric Speech (AIDS) is a validated tool that is used in this outcome to measure speed of language as compared with normal subjects for quantifying speaking rate.
Measured: Administered at 0, 2, and 4 months
Change in Speech Acceptability Over 4 Months
Assessment of Speech Acceptability is a qualitative measure of "conversational understandability" of language as compared with normal subjects. Subjects will be given 6-word sentences to read where five naïve listeners will evaluate the speakers' speech acceptability on a scale of 4. This is a subsection of the AIDS test.
Measured: Administered at 0, 2, and 4 months
Change in Speech and Swallowing Over 4 Months
This is a disease specific, 6-item, administered questionnaire to evaluate post-treatment speech and swallowing ability measure will provide critical data on the socialization of the patient as it relates to speaking and eating.
Measured: Administered at 0, 2, and 4 months
Secondary outcomes (2)
Change in Patient Satisfaction of EPG Biofeedback Over 4 Months
The patient will be given a self-administered questionnaire to assess satisfaction and adoption of biofeedback.
Measured: Administered time 0, 2, and 4 months
Difference in Cost for Intervention versus Standard of Care Over Time
Hospital, personnel and patient cost will be collected. SLP time will be recorded on time sheets. The fuel and parking cost will be imputed based on the first 3 numbers of the postal code.
Measured: Weekly, Up to 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start28 Sep 2018
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Cavity Squamous Cell CarcinomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas Chepeha, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650699
- Sponsor's protocol ID
- 17-5105
- Acronym
- Biofeedback
- Status last verified
- Mar 2024
- First submitted
- 29 May 2018
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Head and Neck Cancer Patients With Biofeedback Training to Improve Speaking and Eating in Public
- ClinicalTrials.gov ID
- NCT03650699
- Acronym / sponsor ID
- Biofeedback / 17-5105
- Conditions
- Oral Cavity Squamous Cell Carcinoma
- Keywords
- Oral Cavity Squamous Cell Carcinoma, Biofeedback, Rehabilitation, Head and Neck Cancer, electropalatography, EPG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 29 Aug 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.
Tongue cancer requires resection and reconstruction that can leave patients disabled with respect to speaking and eating. Impairment of tongue function can have significant impact on social interaction and employment. To try and improve speaking and eating in public, the team at the University Health Network is going to use a special device that is designed to help the patient rehabilitate after tongue cancer treatment.
The research part of this study is to use a special mouthpiece or mold that is like a partial plate for upper dentures that will fit on the roof of the mouth. This mold is embedded with 62 sensors that will allow patients to visualize their tongue position during speech. With the help of a speech therapist, patients can learn different tongue positions important speaking and eating. This whole process is called biofeedback. The visualization of the tongue gives the patient the flexibility to practice at home to and learn different tongue positions important to eating and speaking. In addition, the device will provide the speech pathologist with an opportunity for easier and more precise assessment of the patient's progress which can reduce the need for visits to the hospital. The investigators expect the biofeedback training to improve the patient's speaking and eating.
The study hypothesis is that the biofeedback device will improve speech intelligibility, eating in public, speaking in public, and oral intake scores.
Detailed description
Subjects will be enrolled in either arm of the study for duration of 4 months. Patients that are randomized into study arm 1 will come to the clinic for Speech Language Pathologist (SLP) directed face-to-face rehabilitation for a period of 2 months. The patients will then transition to participate in weekly face-to-face Electropalatography (EPG) biofeedback training. The EPG biofeedback will be used for 2 months. Patients that are randomized into study arm 2 will first undergo a self-directed tongue strengthening program (oral exercises) for a period of 2 months and then transition into EPG biofeedback training.
Although randomization will be used, this is a nonstandard trial because all patients will receive biofeedback EPG. Patients from both study arms will receive biofeedback training after undergoing an SLP directed face-to-face rehabilitation program versus a self-directed tongue strengthening program (oral exercises). The SLP directed face-to-face rehabilitation program or self-directed tongue strengthening program will be initiated at least 2 weeks post-surgery. If the patient is treated with adjuvant radiation, the patient will take a self-directed biofeedback holiday with a target of restarting at least 2 after the completion of adjuvant treatment.
This design was chosen because there is equipoise with respect to the efficacy of the intervention and uncertainty with respect to whether the intervention is most valuable following an SLP directed face-to-face rehabilitation program versus a self-directed tongue strengthening program. The design offers all patients the opportunity to participate in the intervention. This approach will also allow us to analyze between subject change and within subject change.
The A.I.D.S assessment has been in place for approximately 50 years. The mean A.I.D.S. efficiency score (95%CI) in the current pilot study (n=16) is 0.54 (46.0, 62.3). With 33 patients in each group, there will be over 80% power to detect a 10% difference in the speech efficiency score even under the condition that there may be low (rho<0.1) correlation within subject. Higher correlation within subject on the various scores would serve to increase the efficiency of the analysis.
Bivariate comparison will be made between the arms with respect to the primary and secondary outcome variables at each time point.
Linear mixed model will be used to account for multiple measures at multiple time points. The first step will be to compare arms with respect to the primary and secondary outcome variables. For those tests that are significant a backward selected regression will be performed to control for confounders and to look for important effect modifier variables. Variables related to rehabilitation participation will be modeled in the backward selected regression.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Directed Tongue Strengthening Rehab | Experimental | Device: Electropalatography Biofeedback Training8 sessions of self-directed tongue strengthening exercises followed by 8 sessions of electropalatography biofeedback training. Assessments will be taken during the beginning, middle, and end of each study arm. |
| SLP Directed Face-to-Face Rehab | Experimental | Device: Electropalatography Biofeedback Training8 sessions of SLP-directed face-to-face rehabilitation program followed by 8 sessions of electropalatography biofeedback training. Assessments will be taken during the beginning, middle, and end of each study arm. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Oral cavity carcinoma involving the tongue or floor of the mouth
- Primary surgical treatment or/
- Primary surgical treatment with adjuvant radiation therapy or/
- Salvage surgical treatment
- At least 2 weeks post treatment
Key exclusion criteria (4 listed)
- Anatomic palate abnormality that precludes fitting a mouthpiece
- Cognitively unable to participate in biofeedback
- Persistent Cancer
- Does not speak English
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 |
|---|---|---|
| Electropalatography Biofeedback TrainingThe study agent is electropalatography (EPG). The LinguaGraph EPG device is a biofeedback technology that creates a digital visualization of tongue function during speech. The visualization is accomplished by a custom made mouthpiece that fits over the hard palate with 62 sensors that capture tongue position. The information from the sensors in the mouthpiece, as well as the audio output, is processed in an EPG Unit that converts the information from mouthpiece to a visual representation on a computer screen. The visual information with respect to tongue position can be used to provide biofeedback training.The computer can be used in the clinic during a patient visit or it can be seen over the internet with the patient at home and the speech and language pathologist at the clinic. | Device | SLP Directed Face-to-Face Rehab, Self-Directed Tongue Strengthening Rehab |
Primary outcome
Change in Percent Intelligibility of Speech Over 4 Months
Time frame: Administered at 0, 2, and 4 months
Change in percent intelligibility is measured using Assessment of Intelligibility of Dysarthric Speech (AIDS). Assessment of Intelligibility of Dysarthric Speech (AIDS) is a validated tool that is used in this outcome to measure intelligibility as compared with normal subjects for quantifying single-word intelligibility and sentence intelligibility.
Change in Rate of Intelligible Speech Over 4 Months
Time frame: Administered at 0, 2, and 4 months
Change in intelligibility rate is also measured using Assessment of Intelligibility of Dysarthric Speech (AIDS). Assessment of Intelligibility of Dysarthric Speech (AIDS) is a validated tool that is used in this outcome to measure speed of language as compared with normal subjects for quantifying speaking rate.
Change in Speech Acceptability Over 4 Months
Time frame: Administered at 0, 2, and 4 months
Assessment of Speech Acceptability is a qualitative measure of "conversational understandability" of language as compared with normal subjects. Subjects will be given 6-word sentences to read where five naïve listeners will evaluate the speakers' speech acceptability on a scale of 4. This is a subsection of the AIDS test.
Change in Speech and Swallowing Over 4 Months
Time frame: Administered at 0, 2, and 4 months
This is a disease specific, 6-item, administered questionnaire to evaluate post-treatment speech and swallowing ability measure will provide critical data on the socialization of the patient as it relates to speaking and eating.
2 secondary outcomes
Change in Patient Satisfaction of EPG Biofeedback Over 4 Months
Time frame: Administered time 0, 2, and 4 months
Difference in Cost for Intervention versus Standard of Care Over Time
Time frame: Weekly, Up to 16 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 20 Mar 2024.
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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.
Douglas Chepeha, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electropalatography Biofeedback Training in people with Oral Cavity Squamous Cell Carcinoma, 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 5 inclusion and 4 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 20 Mar 2024. 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?
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 Percent Intelligibility of Speech Over 4 Months (time frame: Administered at 0, 2, and 4 months). The study lists 4 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 20 Mar 2024.