Rehabilitation Outcomes in Head and Neck Survivors

Head and Neck Cancer Clinical Trial

— HNC  

Official title:

Rehabilitation Outcomes in Head and Neck Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03206242
• Other study ID #: 104-2300C
• Secondary ID: CGMH-IRB-103-516
• Status: Completed
• Phase: N/A
• First received: February 17, 2015
• Last updated: June 30, 2017
• Start date: January 1, 2015
• Est. completion date: June 30, 2016

Study information

• Verified date: May 2015
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 30, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Physiotherapy
Interventions of physical therapy will be implemented after reconstructive surgery including edema control, scar management, pain management, respiration training, oral function training, neck and shoulder function training, donor site mobility training.

Locations

Country	Name	City	State
Taiwan	Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	return to work as measured by interview		1 year
Primary	quality of life as measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30		1 year
Primary	physical functions measured by 6-minute walking test		1 year
Primary	quality of life as measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-H&N35		1 year
Primary	physical functions measured by time up & go test		1 year
Secondary	shoulder function measured by function-related tests		1 year
Secondary	pain measured by Visual Analog Scale		1 year
Secondary	mouth opening measured by Boley gauge		1 year
Secondary	joint range of motion measured by goniometer		1 year
Secondary	muscle strength measured by manual muscle testing		1 year