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Oral Cancer With Wide Excision and Free Flap Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03776578
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date December 4, 2018
First Posted Date December 14, 2018
Last Update Posted Date December 19, 2018
Estimated Study Start Date January 1, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 12, 2018)
nasogastric tube dependence rate [ Time Frame: 2 years ]
nasogastric tube dependence rate
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03776578 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Oral Cancer With Wide Excision and Free Flap Reconstruction
Official Title Prospective Proactive Swallowing Rehabilitation and Swallow Outcome for Advanced Oral Cancer Patients Treated With Wide Excision and Free Flap Reconstruction
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 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 Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Head and Neck Cancer
Intervention Procedure: swallow fuction and swallow training
nasogastric tube dependence rate
Study Groups/Cohorts
  • 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.
    Intervention: Procedure: swallow fuction and swallow training
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 12, 2018)
80
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Not willing to participate

Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Wen-Hsuan Tseng 0972652672 alts074@gmail.com
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03776578
Other Study ID Numbers 201807023RINA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: protocal,patient treantment course
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Wen-Hsuan Tseng National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date November 2018