Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 79 of 11643 for:    Oral Cancer

Rehabilitation Outcomes in Head and Neck Survivors (HNC)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03206242
Recruitment Status : Completed
First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Head and Neck Cancer Oral Cancer Other: Physiotherapy

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rehabilitation Outcomes in Head and Neck Survivors
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : June 30, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
initial
0 month begin physiotherapy
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.
Other Name: Rehabilitation

3 months after physiotherapy
3 months after physiotherapy
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.
Other Name: Rehabilitation

6 months after physiotherapy
6 months after physiotherapy
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.
Other Name: Rehabilitation




Primary Outcome Measures :
  1. return to work as measured by interview [ Time Frame: 1 year ]
  2. quality of life as measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 [ Time Frame: 1 year ]
  3. physical functions measured by 6-minute walking test [ Time Frame: 1 year ]
  4. quality of life as measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-H&N35 [ Time Frame: 1 year ]
  5. physical functions measured by time up & go test [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. shoulder function measured by function-related tests [ Time Frame: 1 year ]
  2. pain measured by Visual Analog Scale [ Time Frame: 1 year ]
  3. mouth opening measured by Boley gauge [ Time Frame: 1 year ]
  4. joint range of motion measured by goniometer [ Time Frame: 1 year ]
  5. muscle strength measured by manual muscle testing [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects receive physical therapy at Linkou Chang Gung Memorial Hospital will be invited to participate this study.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03206242


Locations
Layout table for location information
Taiwan
Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Layout table for investigator information
Principal Investigator: Yueh-Hsia Chen, Master Chang Gung Memorial Hospital

Publications of Results:

Layout table for additonal information
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03206242     History of Changes
Other Study ID Numbers: 104-2300C
CGMH-IRB-103-5164B ( Registry Identifier: CGMH )
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: May 2015

Keywords provided by Chang Gung Memorial Hospital:
Rehabilitation
Physiotherapy
Trismus
Pain
Return to work
Quality of life

Additional relevant MeSH terms:
Layout table for MeSH terms
Head and Neck Neoplasms
Mouth Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases