Oral Cavity Squamous Cell CarcinomaSPOKENCT05876247
Articulatory Adaptation Following Oral Cancer Treatment
An observational study of Oral Cavity Squamous Cell Carcinoma and Speech Disorders, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial summary
The goal of this longitudinal study is to learn more about the articulatory consequences of surgical oral cancer treatment. The main aims are to study the coordination and development of speech articulation of patients who will undergo surgical treatment for oral cancer longitudinally and whether individual… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Cavity Squamous Cell Carcinoma, Speech Disorders
- What is being tested?
- Electromagnetic Articulography
- How many people
- 50 participants
- Where
- 2 sitesNetherlands
- Study dates
- 10 Nov 2022to Aug 2025
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with and without oral cancer who speak Dutch as their native language
Who may be able to join
- Diagnosed with T1 or T2 tumor in the oral cavity
- At least 18 years old and able to provide informed consent
- Native speaker of Dutch
- Has nog been treated for oral cancer before
Who cannot join
- 1a. Recurrence of disease (for patients)
- 1b. Treated for oral cancer (for healthy controls) 2. Speech problems (e.g., stuttering) 3. Problems with sight or hearing that impede reading or understanding instructions. When glasses or a hearing aid resolve these problems, then participants are not excluded.
- 4. Neurological or psychological disorders (e.g., stroke) 5. Non-removable metal in, on or around the head (piercings, braces, pacemaker, electrodes) 6. Self-reported signs of depression
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Faculty of Arts, University of Groningen
Groningen, 9712 EK
Thomas Tienkamp, MA, +31 50 36 37051, t.b.tienkamp@rug.nl
- Recruiting
University Medical Centre Groningen
Groningen, 9713 GZ
Thomas Tienkamp, MA, +31 50 36 37051, t.b.tienkamp@umcg.nl
About this study
Official title: Speech Flexibility in Adulthood Following Oral Cancer Treatment: Acoustic and Kinematic Explorations
The goal of this longitudinal study is to learn more about the articulatory consequences of surgical oral cancer treatment. The main aims are to study the coordination and development of speech articulation of patients who will undergo surgical treatment for oral cancer longitudinally and whether individual differences in the reliance on auditory or tactile information can predict the success of speech compensatory strategies.
Participants will perform multiple speech tasks while motion tracking sensors track the articulatory gestures.
- Being tested
- Electromagnetic Articulography
- Keywords
- Articulation
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Speech Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic ArticulographyOther
Motion tracking sensors will track articulatory movements of the tongue, jaw and lips
| Study group | Role | What they receive |
|---|---|---|
| Individuals treated for oral cancer | Dutch native speakers (18+) who will undergo surgical treatment for a T1 or T2 tumour on the tongue. Receives: Other: Electromagnetic Articulography | |
| Control speakers | Dutch native speakers (18+) without self-reported speech problems. Receives: Other: Electromagnetic Articulography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Articulatory gestures
Articulatory movements in three dimensions of the tongue, lips and jaw as measured by the NDI Vox Electromagnetic Articulograph. Measures include: articulator speed (mm/s), total displacement (mm), coordinates (x,y,z) during specific gestures.
Measured: 2022-2025
Acoustic outcomes
Speech acoustics will be measured in Praat and include the first and second formants of vowels (in Hz), global movement size in terms of acoustic working space (Hz-squared), and the centre of gravity of sibilants (in Hz)
Measured: 2022-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start10 Nov 2022
- Primary completionAug 2024 (estimated)
- Study completionAug 2025 (estimated)
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 Medical Center GroningenThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Max Witjes, PhD, Principal investigator, University of Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876247
- Sponsor's protocol ID
- METc 2021/711
- Acronym
- SPOKE
- Status last verified
- May 2023
- First submitted
- 16 May 2023
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will share where legally possible.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech Flexibility in Adulthood Following Oral Cancer Treatment: Acoustic and Kinematic Explorations
- ClinicalTrials.gov ID
- NCT05876247
- Acronym / sponsor ID
- SPOKE / METc 2021/711
- Keywords
- Articulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 25 May 2023 (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.
The goal of this longitudinal study is to learn more about the articulatory consequences of surgical oral cancer treatment. The main aims are to study the coordination and development of speech articulation of patients who will undergo surgical treatment for oral cancer longitudinally and whether individual differences in the reliance on auditory or tactile information can predict the success of speech compensatory strategies.
Participants will perform multiple speech tasks while motion tracking sensors track the articulatory gestures.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals treated for oral cancer | – | Other: Electromagnetic ArticulographyDutch native speakers (18+) who will undergo surgical treatment for a T1 or T2 tumour on the tongue. |
| Control speakers | – | Other: Electromagnetic ArticulographyDutch native speakers (18+) without self-reported speech problems. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with and without oral cancer who speak Dutch as their native language
Key inclusion criteria (4 listed)
- Diagnosed with T1 or T2 tumor in the oral cavity
- At least 18 years old and able to provide informed consent
- Native speaker of Dutch
- Has nog been treated for oral cancer before
Key exclusion criteria (3 listed)
- 1a. Recurrence of disease (for patients)
- 1b. Treated for oral cancer (for healthy controls) 2. Speech problems (e.g., stuttering) 3. Problems with sight or hearing that impede reading or understanding instructions. When glasses or a hearing aid resolve these problems, then participants are not excluded.
- 4. Neurological or psychological disorders (e.g., stroke) 5. Non-removable metal in, on or around the head (piercings, braces, pacemaker, electrodes) 6. Self-reported signs of depression
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 |
|---|---|---|
| Electromagnetic ArticulographyMotion tracking sensors will track articulatory movements of the tongue, jaw and lips | Other | Control speakers, Individuals treated for oral cancer |
Primary outcome
Articulatory gestures
Time frame: 2022-2025
Articulatory movements in three dimensions of the tongue, lips and jaw as measured by the NDI Vox Electromagnetic Articulograph. Measures include: articulator speed (mm/s), total displacement (mm), coordinates (x,y,z) during specific gestures.
Acoustic outcomes
Time frame: 2022-2025
Speech acoustics will be measured in Praat and include the first and second formants of vowels (in Hz), global movement size in terms of acoustic working space (Hz-squared), and the centre of gravity of sibilants (in Hz)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Individual participant dataSharing planned: Undecided. Will share where legally possible.
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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.
Max Witjes, PhD principal investigator
University of Groningen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Cavity Squamous Cell Carcinoma and Speech Disorders, run by University Medical Center Groningen at 2 sites in Netherlands.
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 3 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: status not confirmed, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Tienkamp, MA (+31 50 36 37051, t.b.tienkamp@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Articulatory gestures (time frame: 2022-2025). 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 30 May 2023.