Rehabilitation Outcomes in Head and Neck Survivors

Completed

• Conditions: Oral Cancer; Head and Neck Cancer
• Interventions: Other: Physiotherapy

• Registration Number: NCT03206242
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

Head and neck cancer is prevalent in Taiwan, and oral cancer is the most common location. Patients with advanced stage of the disease need extensive tumor excision with neck dissection. Secondary reconstructive surgeries using free flap could improve the postoperative function or appearance of cancer survivors. Advanced treatments make survival rates increased. Effects of treatment for oral cancer develop shoulder dysfunction, speech, mastication, donor site morbidity and psychological issues. Physical therapy may have benefits for temporomandibular joint function, shoulder pain relief, muscle performance, and oral structures coordination. Return to work in the number of cancer survivors is a realistic outcome. Rehabilitation effects on functional restorations and quality of life for head and neck survivors are needed for further studied.

The purpose of this project is to explore the rehabilitation effects following head and neck reconstructive survivors. The investigators measure temporomandibular joint function, shoulder function, pain monthly. Physical functions, self-reported quality of life, and the status of return to work are measured 3 and 6 months after surgery. This prospective study could help to predict the rehabilitation outcomes and benefits.

Detailed Description

Head and neck cancer is prevalent in Taiwan, and oral cancer is the most common location. Patients with advanced stage of the disease need extensive tumor excision with neck dissection. Secondary reconstructive surgeries using free flap could improve the postoperative function or appearance of cancer survivors. Oral functions include respiration, speech, mastication, deglutition, and cosmetics. Advanced treatments make survival rates increased, but might develop shoulder dysfunction, speech, mastication, donor site morbidity and psychological issues. The purpose of this project is to explore the effects of rehabilitation following reconstructive surgery in oral cancer survivors.

This study design is an interrupted time-series design. The investigators will recruit 50 subjects one week following reconstructive surgery. The measurements include manual muscle strength, joint range of motion, maximal mouth opening, pain status, hand-to-neck test, hand-to-scapula test, hand-to-opposite-scapula test, 6-minute walking test, timed up \& go test, European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30, European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-H\&N35 and return-to-work. These tests were done at the first visit (0 week post-operation), three months and six months after reconstructive surgery respectively. The intervention programs consist of edema control, scar management, pain management, respiration training, oral function training, neck and shoulder function training, donor site mobility training. Continuous variables were analyzed by descriptive statistics. One-way ANOVA was used to compare the difference between measurements. Binary logistic regression was used to predict the factors of return-to-work.

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2015-02-17
• Status Verified: 2015-05
• Primary Completion: 2016-06-30
• Study Completion: 2016-06-30
• Study First Submitted QC: 2017-06-30
• Last Update Submitted: 2017-06-30
• Study First Posted: 2017-07-02
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Clinical diagnosis of oral cancer
• Post-reconstructive surgery
• Age between 20 to 65 years old
• Must be able to follow instructions

Exclusion Criteria

• Central nervous disease
• Metastasis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
3 months after physiotherapy	Physiotherapy	3 months after physiotherapy
6 months after physiotherapy	Physiotherapy	6 months after physiotherapy
initial	Physiotherapy	0 month begin physiotherapy

Primary Outcome Measures

Name	Time	Method
return to work as measured by interview	1 year
quality of life as measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30	1 year
physical functions measured by 6-minute walking test	1 year
quality of life as measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-H&N35	1 year
physical functions measured by time up & go test	1 year

Secondary Outcome Measures

Name	Time	Method
shoulder function measured by function-related tests	1 year
pain measured by Visual Analog Scale	1 year
joint range of motion measured by goniometer	1 year
mouth opening measured by Boley gauge	1 year
muscle strength measured by manual muscle testing	1 year

Trial Locations

Locations (1)

Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan