The Swallowing ChangesNCT07000032
The Swallowing Function of Oral Cancer Surgery
An observational study of The Swallowing Changes, run by National Taiwan University Hospital.
Trial summary
This study enrolled patients who underwent oral cancer resection. Swallowing function, muscle status, and nutritional status were assessed before treatment, one month after treatment, and between three months to one year post-treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- The Swallowing Changes
- Type of treatment
- Pill or oral medicine
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2025to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: patients undergoing oral cancer surgery
Who may be able to join
- patients undergoing oral cancer
Who cannot join
- patients unable to unable to cooperate with the examination
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Longitudinal Study on Dysphagia and Associated Nutritional Complications Following Oral Cancer Surgery
This study enrolled patients who underwent oral cancer resection. Swallowing function, muscle status, and nutritional status were assessed before treatment, one month after treatment, and between three months to one year post-treatment.
Read the detailed description
Dysphagia is a common and debilitating symptom among patients who undergo oral cancer resection with reconstruction followed by adjuvant radiotherapy. During the course of the disease, approximately 20% to 98% of patients experience swallowing difficulties. This is primarily caused by tumor destruction, postoperative sequelae from surgical resection, and the adverse effects of radiotherapy and chemotherapy. The use of chemotherapy or radiotherapy-particularly when combined-increases the incidence of complications such as oropharyngeal mucositis, odynophagia, dysgeusia, xerostomia, nausea, vomiting, and fatigue. These complications may lead to dehydration and significant weight loss, which in turn negatively impact nutritional status, functional ability, and quality of life.
This study enrolled patients who underwent oral cancer surgery. Swallowing function, muscle status, and nutritional status were assessed before treatment, one month after treatment, and between three months to one year post-treatment.
- Conditions
- The Swallowing Changes
- Being tested
- No Intervention: Observational Cohort
- Keywords
- oral cancer surgery, swallowing, nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
This is an observational cohort
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing oral cancer surgery | patients undergoing oral cancer surgery Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
bolus presence time
The opening of hypopharynx
Measured: one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start15 Jun 2025 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Swallowing ChangesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000032
- Sponsor's protocol ID
- 202501062RINA
- Status last verified
- Mar 2025
- First submitted
- 23 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethical issue
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study on Dysphagia and Associated Nutritional Complications Following Oral Cancer Surgery
- ClinicalTrials.gov ID
- NCT07000032
- Acronym / sponsor ID
- 202501062RINA
- Conditions
- The Swallowing Changes
- Keywords
- oral cancer surgery, swallowing, nutrition
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 31 May 2025 (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.
This study enrolled patients who underwent oral cancer resection. Swallowing function, muscle status, and nutritional status were assessed before treatment, one month after treatment, and between three months to one year post-treatment.
Detailed description
Dysphagia is a common and debilitating symptom among patients who undergo oral cancer resection with reconstruction followed by adjuvant radiotherapy. During the course of the disease, approximately 20% to 98% of patients experience swallowing difficulties. This is primarily caused by tumor destruction, postoperative sequelae from surgical resection, and the adverse effects of radiotherapy and chemotherapy. The use of chemotherapy or radiotherapy-particularly when combined-increases the incidence of complications such as oropharyngeal mucositis, odynophagia, dysgeusia, xerostomia, nausea, vomiting, and fatigue. These complications may lead to dehydration and significant weight loss, which in turn negatively impact nutritional status, functional ability, and quality of life.
This study enrolled patients who underwent oral cancer surgery. Swallowing function, muscle status, and nutritional status were assessed before treatment, one month after treatment, and between three months to one year post-treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing oral cancer surgery | – | Other: No Intervention: Observational Cohortpatients undergoing oral cancer surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing oral cancer surgery
Key inclusion criteria (1 listed)
- patients undergoing oral cancer
Key exclusion criteria (1 listed)
- patients unable to unable to cooperate with the examination
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 |
|---|---|---|
| No Intervention: Observational CohortThis is an observational cohort | Other | patients undergoing oral cancer surgery |
Primary outcome
bolus presence time
Time frame: one year after surgery
The opening of hypopharynx
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No. Due to ethical issue
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of The Swallowing Changes, run by National Taiwan University Hospital.
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 1 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: opening soon, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chih-Jun Lai, MD, PhD (+886-972652086, littlecherrytw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bolus presence time (time frame: one year after surgery). 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 31 May 2025.