Oral Cavity CancerNCT05056064
Efficacy of Swallowing Function After Early Postoperative Oral Exercise Among Patient With Oral Cavity Cancer Underwent Flap Reconstruction
A study testing Oral exercise in people with Oral Cavity Cancer, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
Efficacy of swallowing function after early postoperative oral exercise among patient with oral cavity cancer underwent flap reconstruction: A randomized controlled trial Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cavity Cancer
- What is being tested?
- Oral exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2021to 31 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with CA tongue and tumor size 2 cm
Who cannot join
- previous treatment
- history of head and neck cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Swallowing Function After Early Postoperative Oral Exercise Among Patient With Oral Cavity Cancer Underwent Flap Reconstruction: A Randomized Controlled Trial
Efficacy of swallowing function after early postoperative oral exercise among patient with oral cavity cancer underwent flap reconstruction: A randomized controlled trial
- Conditions
- Oral Cavity Cancer
- Being tested
- Oral exercise
- Keywords
- Dysphagia, oral cancer, oral exercise
- Medical subject headings
- Mouth Neoplasms, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral exerciseOther
exercise remain tongue
| Study group | Role | What they receive |
|---|---|---|
| CA oral cavity | Experimental | Standard Treatment+Oral exercise Receives: Other: Oral exercise |
| control | No intervention | Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy swallowing function
Efficacy of swallowing function evaluate by Penetration-Aspiration scale by Rosenbek, this questionnaire classify patient for 8 score, from no entry of material into the larynx or trachea to material enters the trachea with no attempt to clear
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start1 Jan 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Cavity CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056064
- Sponsor's protocol ID
- 63222
- Status last verified
- Nov 2021
- First submitted
- 5 Sep 2021
- Last updated
- 25 Jan 2024
- 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 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Swallowing Function After Early Postoperative Oral Exercise Among Patient With Oral Cavity Cancer Underwent Flap Reconstruction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05056064
- Acronym / sponsor ID
- 63222
- Conditions
- Oral Cavity Cancer
- Keywords
- Dysphagia, oral cancer, oral exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 24 Sep 2021 (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.
Efficacy of swallowing function after early postoperative oral exercise among patient with oral cavity cancer underwent flap reconstruction: A randomized controlled trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CA oral cavity | Experimental | Other: Oral exerciseStandard Treatment+Oral exercise |
| control | No intervention | –Standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient with CA tongue and tumor size 2 cm
Key exclusion criteria (2 listed)
- previous treatment
- history 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 |
|---|---|---|
| Oral exerciseexercise remain tongue | Other | CA oral cavity |
Primary outcome
Efficacy swallowing function
Time frame: 1 year
Efficacy of swallowing function evaluate by Penetration-Aspiration scale by Rosenbek, this questionnaire classify patient for 8 score, from no entry of material into the larynx or trachea to material enters the trachea with no attempt to clear
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 25 Jan 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral exercise in people with Oral Cavity Cancer, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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 1 inclusion and 2 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 25 Jan 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 Thailand. 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?
Efficacy swallowing function (time frame: 1 year). 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 25 Jan 2024.