Oral Cancer With Wide Excision and Free Flap Reconstruction

Head and Neck Cancer Clinical Trial

Official title:

Prospective Proactive Swallowing Rehabilitation and Swallow Outcome for Advanced Oral Cancer Patients Treated With Wide Excision and Free Flap Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03776578
• Other study ID #: 201807023RINA
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: November 2018
• Source: National Taiwan University Hospital
• Contact: Wen-Hsuan Tseng
• Phone: 0972652672
• Email: alts074[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 1, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Not willing to participate

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Mouth Neoplasms

Intervention

Procedure:
• swallow fuction and swallow training
nasogastric tube dependence rate

Locations

Country	Name	City	State
Taiwan	Wen-Hsuan Tseng	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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 — View Citation

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. — View Citation

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. — View Citation

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/ — View Citation

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;(8):CD011112. doi: 10.1002/14651858.CD011112.pub2. Revi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nasogastric tube dependence rate	nasogastric tube dependence rate	2 years