Swallowing FunctionNCT06747208
Dysphagia in Head and Neck Cancer With Radiation
An observational study of Swallowing Function, run by National Taiwan University Hospital.
Trial summary
This study focuses on swallowing dysfunction, a common issue affecting 60-75% of head and neck cancer patients due to tumor damage, treatment complications, and chemoradiotherapy side effects, which can lead to malnutrition and reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Swallowing Function
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2031
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with head and neck cancer undergoing radiation therapy
Who may be able to join
- Patients scheduled to undergo radiotherapy or concurrent chemoradiotherapy ;
- Aged between 18 and 80 years;
- Able to perform self-care independently (ECOG ≤ 2);
- All patients provide written informed consent.
Who cannot join
- Patients scheduled to undergo surgical treatment;
- Patients with neuromuscular diseases, such as stroke or Parkinson's disease;
- Patients with other diseases or complications, including heart disease classified as NYHA functional class ≥ 2 with thrombotic conditions, or lung disease classified as Hugh-Jones grade ≥ 4;
- Patients with psychological disorders that may affect their ability to provide informed consent or comply with the study protocol;
- Patients who do not consent to undergo high-resolution impedance manometry.
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: The Impact of Swallowing and Nutrition in Head and Neck Cancer Patients Undergoing Chemo or Chemo-radiotherapy.
This study focuses on swallowing dysfunction, a common issue affecting 60-75% of head and neck cancer patients due to tumor damage, treatment complications, and chemoradiotherapy side effects, which can lead to malnutrition and reduced quality of life. With limited research on the effects of radiation doses on swallowing muscles and nutrition, this study aims to evaluate these impacts in non-surgical patients undergoing radiotherapy, conducting assessments before treatment, three months after, and within one year post-treatment.
Read the detailed description
Swallowing dysfunction is a common and debilitating symptom in head and neck cancer patients, affecting approximately 60-75% during the disease course, primarily due to tumor destruction, postoperative complications, and side effects of radiotherapy and chemotherapy. Combined chemoradiotherapy exacerbates adverse effects, such as mucositis, odynophagia, taste alterations, xerostomia, nausea, vomiting, and fatigue, which can result in dehydration, significant weight loss, and detrimental impacts on nutritional status, functionality, and quality of life. Limited research exists on the effects of radiation and chemoradiation doses on swallowing muscles, quality of life, and nutritional changes in these patients. This study aims to evaluate the impact of radiation doses on swallowing muscles and quality of life in head and neck cancer patients undergoing chemoradiotherapy while identifying malnutrition risk in this population. Non-surgical patients receiving radiotherapy as the primary treatment will be recruited, with swallowing, muscle, and nutritional assessments conducted before treatment, three months after treatment, and within one year post-treatment.
- Conditions
- Swallowing Function
- Keywords
- dysphagia, head and neck cancer, radiation therapy
- Medical subject headings
- Deglutition Disorders, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| head and neck cancer patients | patients with head and neck cancer undergoing radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypopharyngeal mean peak pressure
hypopharyngeal contraction
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swallowing FunctionStudies 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
- 50 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
- NCT06747208
- Sponsor's protocol ID
- 202410077DINE
- Status last verified
- Dec 2024
- First submitted
- 15 Dec 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Swallowing and Nutrition in Head and Neck Cancer Patients Undergoing Chemo or Chemo-radiotherapy.
- ClinicalTrials.gov ID
- NCT06747208
- Acronym / sponsor ID
- 202410077DINE
- Conditions
- Swallowing Function
- Keywords
- dysphagia, head and neck cancer, radiation therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 24 Dec 2024 (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 focuses on swallowing dysfunction, a common issue affecting 60-75% of head and neck cancer patients due to tumor damage, treatment complications, and chemoradiotherapy side effects, which can lead to malnutrition and reduced quality of life. With limited research on the effects of radiation doses on swallowing muscles and nutrition, this study aims to evaluate these impacts in non-surgical patients undergoing radiotherapy, conducting assessments before treatment, three months after, and within one year post-treatment.
Detailed description
Swallowing dysfunction is a common and debilitating symptom in head and neck cancer patients, affecting approximately 60-75% during the disease course, primarily due to tumor destruction, postoperative complications, and side effects of radiotherapy and chemotherapy. Combined chemoradiotherapy exacerbates adverse effects, such as mucositis, odynophagia, taste alterations, xerostomia, nausea, vomiting, and fatigue, which can result in dehydration, significant weight loss, and detrimental impacts on nutritional status, functionality, and quality of life. Limited research exists on the effects of radiation and chemoradiation doses on swallowing muscles, quality of life, and nutritional changes in these patients. This study aims to evaluate the impact of radiation doses on swallowing muscles and quality of life in head and neck cancer patients undergoing chemoradiotherapy while identifying malnutrition risk in this population. Non-surgical patients receiving radiotherapy as the primary treatment will be recruited, with swallowing, muscle, and nutritional assessments conducted before treatment, three months after treatment, and within one year post-treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| head and neck cancer patients | – | –patients with head and neck cancer undergoing radiation therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with head and neck cancer undergoing radiation therapy
Key inclusion criteria (4 listed)
- Patients scheduled to undergo radiotherapy or concurrent chemoradiotherapy ;
- Aged between 18 and 80 years;
- Able to perform self-care independently (ECOG ≤ 2);
- All patients provide written informed consent.
Key exclusion criteria (5 listed)
- Patients scheduled to undergo surgical treatment;
- Patients with neuromuscular diseases, such as stroke or Parkinson's disease;
- Patients with other diseases or complications, including heart disease classified as NYHA functional class ≥ 2 with thrombotic conditions, or lung disease classified as Hugh-Jones grade ≥ 4;
- Patients with psychological disorders that may affect their ability to provide informed consent or comply with the study protocol;
- Patients who do not consent to undergo high-resolution impedance manometry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hypopharyngeal mean peak pressure
Time frame: one year
hypopharyngeal contraction
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 24 Dec 2024.
- Individual participant dataSharing planned: No. due to ethical issue
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Evaluation of the Impact of Periodontitis and Its Treatment on Swallowing Functions and Oral Quality of Life
Periodontitis, Periodontal Diseases
Not yet recruiting
Standardizing Swallow Pressure Measurements
Dysphagia
Recruiting
The Effectiveness of Structured Swallowing Exercise Therapy in Patients With Nasopharyngeal Carcinoma: An Assessment of Swallowing Function and Quality of Life
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RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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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 Swallowing Function, 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 4 inclusion and 5 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 24 Dec 2024. 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 (+886-965327939, littlecherrytw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hypopharyngeal mean peak pressure (time frame: one 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 24 Dec 2024.