Oral Cancer With Wide Excision and Free Flap Reconstruction

NCT03776578 | Unknown DMC

• 1 other identifier: 201807023RINA
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• nasogastric tube dependence rate

  nasogastric tube dependence rate

  2 years

Study Arms (2)

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.

Procedure: swallow fuction and swallow training

Interventions

swallow fuction and swallow training PROCEDURE

nasogastric tube dependence rate

Head and neck Cancer surgery treatment and rehabilitation

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Not willing to participate

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Wen-Hsuan Tseng

Taipei, 10002, Taiwan

RECRUITING

Related Publications (5)

• 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.

  PMID: 27485284 BACKGROUND

• Goepfert 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.

  PMID: 27440393 BACKGROUND

• Perry 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.

  PMID: 27562477 RESULT

• Kraaijenga 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.

  PMID: 28766850 RESULT

• Ajmani 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.

  PMID: 29710108 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Wen-Hsuan Tseng

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen-Hsuan Tseng

CONTACT

0972652672; alts074@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 14, 2018
• Study Start: January 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: September 1, 2021
• Last Updated: December 19, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)