Head and Neck CancerNCT03776578
Oral Cancer With Wide Excision and Free Flap Reconstruction
An observational study of Head and Neck Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
A proactive speech-language pathologist program can be successfully established as part of the multidisciplinary care of patients with head and neck squamous cell carcinoma and improve patient quality of life. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- swallow fuction and swallow training
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2019to 1 Sep 2021
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For all outcome measures, descriptive statistics were generated. Statistical analysis will be performed using the Statistical Package of Social Sciences (SPSS) software version 23.0.
Who may be able to join
- Advanced Oral Cancer Patients Treated with Wide Excision and Free Flap Reconstruction
Who cannot join
- Not willing to participate
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Wen-Hsuan Tseng
Taipei, 10002
Wen-Hsuan Tseng, 0972652672, alts074@gmail.com
About this study
Official title: Prospective Proactive Swallowing Rehabilitation and Swallow Outcome for Advanced Oral Cancer Patients Treated With Wide Excision and Free Flap Reconstruction
A proactive speech-language pathologist program can be successfully established as part of the multidisciplinary care of patients with head and neck squamous cell carcinoma and improve patient quality of life.
Read the detailed description
Head and neck cancer treatment has developed over the last decade, with improved mortality and survival rates, but the treatments often result in dysphagia (a difficulty in swallowing) as a side effect. Swallowing function is affected by the tumor itself, surgical resection of the lesion and neoadjuvant chemoradiation therapy. It is well accepted that pre-treatment swallow function is indicative of post-treatment status and is helpful in identifying patients with high risk of aspiration and dysphagia. In recent years, the concept of "use it, or lose it" has been widely advocated by specialists. Preventive swallowing rehabilitation including evaluation patient's swallowing function and propose rehabilitation and adaptive maneuver or change in food texture. The aim is to ensure safe swallowing and prevent deglutitive muscles from deconditioning. Moreover, aspiration can be prevented and adequate nutrition was maintained through the cancer treatment course. Investigators include patients with advanced oral cavity cancer who were treated by radical operation and free flap reconstruction, and provided them with preventive swallowing rehabilitation. Investigators then analyze the swallowing function, oral intake status, and nasogastric tube dependence rate and tracheostomy tube dependence rate.The participants received interventions as part of our routine medical care, and Investigators studied the effect of the intervention.
- Conditions
- Head and Neck Cancer
- Being tested
- swallow fuction and swallow training
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
swallow fuction and swallow trainingProcedure or surgery
nasogastric tube dependence rate
| Study group | Role | What they receive |
|---|---|---|
| Head and neck Cancer surgery not treatment and rehabilitation | The patients with oral cavity cancer who weren't treated by radical operation and free flap reconstruction,and can't provide them with preventive swallowing rehabilitation | |
| Head and neck Cancer surgery treatment and rehabilitation | Head and neck cancer treatment has developed over the last decade, with improved mortality and survival rates, It is well accepted that pre-treatment swallow function is indicative of post-treatment status and is helpful in identifying patients with high risk of aspiration and dysphagia.Preventive swallowing rehabilitation including evaluation patient's swallowing function and propose rehabilitation and adaptive maneuver or change in food texture. The aim is to ensure safe swallowing and prevent deglutitive muscles from deconditioning. Investigators include patients with advanced oral cavity cancer who were treated by radical operation and free flap reconstruction, and provided them with preventive swallowing rehabilitation.Investigators then analyze the swallowing function, oral intake status, and nasogastric tube dependence rate and tracheostomy tube dependence rate. Receives: Procedure: swallow fuction and swallow training |
What is being measured
The primary outcome is the main question the study is designed to answer.
nasogastric tube dependence rate
nasogastric tube dependence rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start1 Jan 2019 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen-Hsuan Tseng, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776578
- Sponsor's protocol ID
- 201807023RINA
- Status last verified
- Nov 2018
- First submitted
- 4 Dec 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: protocal,patient treantment course
Publications
Goepfert RP, Lewin JS, Barrow MP, Gunn GB, Fuller CD, Beadle BM, Garden AS, Rosenthal DI, Kies MS, Papadimitrakopoulou V, Lai SY, Gross ND, Schwartz DL, Hutcheson KA. Long-Term, Prospective Performance of the MD Anderson Dysphagia Inventory in "Low-Intermediate Risk" Oropharyngeal Carcinoma After Intensity Modulated Radiation Therapy. Int J Radiat Oncol Biol Phys. 2017 Mar 15;97(4):700-708. doi: 10.1016/j.ijrobp.2016.06.010. Epub 2016 Jun 15.
PubMed 27485284Goepfert RP, Lewin JS, Barrow MP, Fuller CD, Lai SY, Song J, Hobbs BP, Gunn GB, Beadle BM, Rosenthal DI, Garden AS, Kies MS, Papadimitrakopoulou VA, Schwartz DL, Hutcheson KA. Predicting two-year longitudinal MD Anderson Dysphagia Inventory outcomes after intensity modulated radiotherapy for locoregionally advanced oropharyngeal carcinoma. Laryngoscope. 2017 Apr;127(4):842-848. doi: 10.1002/lary.26153. Epub 2016 Jul 21.
PubMed 27440393Perry A, Lee SH, Cotton S, Kennedy C. Therapeutic exercises for affecting post-treatment swallowing in people treated for advanced-stage head and neck cancers. Cochrane Database Syst Rev. 2016 Aug 26;2016(8):CD011112. doi: 10.1002/14651858.CD011112.pub2.
PubMed 27562477Kraaijenga SAC, Molen LV, Stuiver MM, Takes RP, Al-Mamgani A, Brekel MWMVD, Hilgers FJM. Efficacy of a novel swallowing exercise program for chronic dysphagia in long-term head and neck cancer survivors. Head Neck. 2017 Oct;39(10):1943-1961. doi: 10.1002/hed.24710. Epub 2017 Aug 2.
PubMed 28766850Ajmani GS, Nocon CC, Brockstein BE, Campbell NP, Kelly AB, Allison J, Bhayani MK. Association of a Proactive Swallowing Rehabilitation Program With Feeding Tube Placement in Patients Treated for Pharyngeal Cancer. JAMA Otolaryngol Head Neck Surg. 2018 Jun 1;144(6):483-488. doi: 10.1001/jamaoto.2018.0278.
PubMed 29710108
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Proactive Swallowing Rehabilitation and Swallow Outcome for Advanced Oral Cancer Patients Treated With Wide Excision and Free Flap Reconstruction
- ClinicalTrials.gov ID
- NCT03776578
- Acronym / sponsor ID
- 201807023RINA
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 14 Dec 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.
A proactive speech-language pathologist program can be successfully established as part of the multidisciplinary care of patients with head and neck squamous cell carcinoma and improve patient quality of life.
Detailed description
Head and neck cancer treatment has developed over the last decade, with improved mortality and survival rates, but the treatments often result in dysphagia (a difficulty in swallowing) as a side effect. Swallowing function is affected by the tumor itself, surgical resection of the lesion and neoadjuvant chemoradiation therapy. It is well accepted that pre-treatment swallow function is indicative of post-treatment status and is helpful in identifying patients with high risk of aspiration and dysphagia. In recent years, the concept of "use it, or lose it" has been widely advocated by specialists. Preventive swallowing rehabilitation including evaluation patient's swallowing function and propose rehabilitation and adaptive maneuver or change in food texture. The aim is to ensure safe swallowing and prevent deglutitive muscles from deconditioning. Moreover, aspiration can be prevented and adequate nutrition was maintained through the cancer treatment course. Investigators include patients with advanced oral cavity cancer who were treated by radical operation and free flap reconstruction, and provided them with preventive swallowing rehabilitation. Investigators then analyze the swallowing function, oral intake status, and nasogastric tube dependence rate and tracheostomy tube dependence rate.The participants received interventions as part of our routine medical care, and Investigators studied the effect of the intervention.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Head and neck Cancer surgery not treatment and rehabilitation | – | –The patients with oral cavity cancer who weren't treated by radical operation and free flap reconstruction,and can't provide them with preventive swallowing rehabilitation |
| Head and neck Cancer surgery treatment and rehabilitation | – | Procedure: swallow fuction and swallow trainingHead and neck cancer treatment has developed over the last decade, with improved mortality and survival rates, It is well accepted that pre-treatment swallow function is indicative of post-treatment status and is helpful in identifying patients with high risk of aspiration and dysphagia.Preventive swallowing rehabilitation including evaluation patient's swallowing function and propose rehabilitation and adaptive maneuver or change in food texture. The aim is to ensure safe swallowing and prevent deglutitive muscles from deconditioning. Investigators include patients with advanced oral cavity cancer who were treated by radical operation and free flap reconstruction, and provided them with preventive swallowing rehabilitation.Investigators then analyze the swallowing function, oral intake status, and nasogastric tube dependence rate and tracheostomy tube dependence rate. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For all outcome measures, descriptive statistics were generated. Statistical analysis will be performed using the Statistical Package of Social Sciences (SPSS) software version 23.0.
Key inclusion criteria (1 listed)
- Advanced Oral Cancer Patients Treated with Wide Excision and Free Flap Reconstruction
Key exclusion criteria (1 listed)
- Not willing to participate
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 |
|---|---|---|
| swallow fuction and swallow trainingnasogastric tube dependence rate | Procedure or surgery | Head and neck Cancer surgery treatment and rehabilitation |
Primary outcome
nasogastric tube dependence rate
Time frame: 2 years
nasogastric tube dependence rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Background: PubMed 27485284Goepfert RP, Lewin JS, Barrow MP, Gunn GB, Fuller CD, Beadle BM, Garden AS, Rosenthal DI, Kies MS, Papadimitrakopoulou V, Lai SY, Gross ND, Schwartz DL, Hutcheson KA. Long-Term, Prospective Performance of the MD Anderson Dysphagia Inventory in "Low-Intermediate Risk" Oropharyngeal Carcinoma After Intensity Modulated Radiation Therapy. Int J Radiat Oncol Biol Phys. 2017 Mar 15;97(4):700-708. doi: 10.1016/j.ijrobp.2016.06.010. Epub 2016 Jun 15.
- Background: PubMed 27440393Goepfert RP, Lewin JS, Barrow MP, Fuller CD, Lai SY, Song J, Hobbs BP, Gunn GB, Beadle BM, Rosenthal DI, Garden AS, Kies MS, Papadimitrakopoulou VA, Schwartz DL, Hutcheson KA. Predicting two-year longitudinal MD Anderson Dysphagia Inventory outcomes after intensity modulated radiotherapy for locoregionally advanced oropharyngeal carcinoma. Laryngoscope. 2017 Apr;127(4):842-848. doi: 10.1002/lary.26153. Epub 2016 Jul 21.
- Results publication: PubMed 27562477Perry A, Lee SH, Cotton S, Kennedy C. Therapeutic exercises for affecting post-treatment swallowing in people treated for advanced-stage head and neck cancers. Cochrane Database Syst Rev. 2016 Aug 26;2016(8):CD011112. doi: 10.1002/14651858.CD011112.pub2.
- Results publication: PubMed 28766850Kraaijenga SAC, Molen LV, Stuiver MM, Takes RP, Al-Mamgani A, Brekel MWMVD, Hilgers FJM. Efficacy of a novel swallowing exercise program for chronic dysphagia in long-term head and neck cancer survivors. Head Neck. 2017 Oct;39(10):1943-1961. doi: 10.1002/hed.24710. Epub 2017 Aug 2.
- Results publication: PubMed 29710108Ajmani GS, Nocon CC, Brockstein BE, Campbell NP, Kelly AB, Allison J, Bhayani MK. Association of a Proactive Swallowing Rehabilitation Program With Feeding Tube Placement in Patients Treated for Pharyngeal Cancer. JAMA Otolaryngol Head Neck Surg. 2018 Jun 1;144(6):483-488. doi: 10.1001/jamaoto.2018.0278.
- Individual participant dataSharing planned: No. protocal,patient treantment course
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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.
Wen-Hsuan Tseng principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 19 Dec 2018. 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 Taiwan. 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 Wen-Hsuan Tseng (0972652672, alts074@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nasogastric tube dependence rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03776578, which also lists 5 linked publications.
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 19 Dec 2018.