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Trial record 2 of 292311 for:    ALL

Oral Cancer With Wide Excision and Free Flap Reconstruction

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ClinicalTrials.gov Identifier: NCT03776578
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief 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 (HNSCC) and improve patient quality of life.

Condition or disease Intervention/treatment
Head and Neck Cancer Procedure: swallow fuction and swallow training

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. We include patients with advanced oral cavity cancer who were treated by radical operation and free flap reconstruction, and provided them with preventive swallowing rehabilitation. We 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 we studied the effect of the intervention.

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Other
Time Perspective: Other
Official Title: Prospective Proactive Swallowing Rehabilitation and Swallow Outcome for Advanced Oral Cancer Patients Treated With Wide Excision and Free Flap Reconstruction
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : September 1, 2021


Group/Cohort Intervention/treatment
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. We include patients with advanced oral cavity cancer who were treated by radical operation and free flap reconstruction, and provided them with preventive swallowing rehabilitation. We then analyze the swallowing function, oral intake status, and nasogastric tube dependence rate and tracheostomy tube dependence rate.
Procedure: swallow fuction and swallow training
nasogastric tube dependence rate




Primary Outcome Measures :
  1. nasogastric tube dependence rate [ Time Frame: 2 years ]
    nasogastric tube dependence rate



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

Advanced Oral Cancer Patients Treated with Wide Excision and Free Flap Reconstruction

Exclusion Criteria:

Not willing to participate


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03776578


Contacts
Contact: Wen-Hsuan Tseng 0972652672 alts074@gmail.com

Locations
Taiwan
Wen-Hsuan Tseng Recruiting
Taipei, Taiwan, 10002
Contact: Wen-Hsuan Tseng    0972652672    alts074@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Wen-Hsuan Tseng National Taiwan University Hospital

Publications of Results:
Other Publications:
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03776578     History of Changes
Other Study ID Numbers: 201807023RINA
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: protocal,patient treantment course

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Head and Neck Neoplasms
Mouth Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases