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Trial record 4 of 171 for:    "Lip and oral cavity cancer"

Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors

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ClinicalTrials.gov Identifier: NCT03545100
Recruitment Status : Recruiting
First Posted : June 4, 2018
Last Update Posted : June 7, 2018
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. Advanced treatment of oral cancer increases survival rates; however, it also increases the risk of developing shoulder dysfunction, dysphagia, oral dysfunction, donor site morbidity and psychological issues. The probability of shoulder dysfunction after neck dissection is as high as 70%. Rehabilitation effects on shoulder function for head and neck survivors are needed for further studied.The purpose of this randomized clinical trial is to explore the effects of rehabilitation for shoulder function in oral cancer survivors.

Condition or disease Intervention/treatment Phase
Oral Cancer Other: motor control therapy Other: regular physical therapy Not Applicable

Detailed Description:

Head and neck cancer is prevalent in Taiwan, and oral cancer is the most common location. Advanced treatment of oral cancer increases survival rates; however, it also increases the risk of developing shoulder dysfunction, dysphagia, oral dysfunction, donor site morbidity and psychological issues. The probability of shoulder dysfunction after neck dissection is as high as 70%. Rehabilitation effects on shoulder function for head and neck survivors are needed for further studied.

The purpose of this randomized clinical trial is to explore the effects of rehabilitation for shoulder function in oral cancer survivors. We will recruit 60 newly diagnosed oral cancer subjects through the plastic surgeon's referral from April 2018 to March 2020. The participants will be randomized separated into experimental or control group. Each group would receive regular physical therapy for shoulder function (i.e., transcutaneous electrical stimulation, shoulder joint range of motion exercise, scapular muscle strengthening training). Experimental group would be supplemented by motor control therapy targeting the scapular muscle progressive resistance exercise (exercise plus manual therapy).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : February 6, 2019
Estimated Study Completion Date : February 6, 2019


Arm Intervention/treatment
Experimental: experimental group
motor control therapy
Other: motor control therapy
scapular muscle progressive resistive exercise(PRE)

Other: regular physical therapy
transcutaneous electrical nerve stimulation(TENS), shoulder joint ROM, scapular muscle PRE

Active Comparator: control group
regular physical therapy
Other: regular physical therapy
transcutaneous electrical nerve stimulation(TENS), shoulder joint ROM, scapular muscle PRE




Primary Outcome Measures :
  1. quality of life C-30 [ Time Frame: 1 year ]
    European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30

  2. quality of life H&N35 [ Time Frame: 1 year ]
    European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-H&N35

  3. surface electromyography (SEMG) [ Time Frame: 1 year ]
    European Organization for Research and Treatment of Cancer (EORTC) quality of life surface electromyography

  4. shoulder function [ Time Frame: 1 year ]
    the Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure for upper extremity function


Secondary Outcome Measures :
  1. pain [ Time Frame: 1 year ]
    Visual Analog Scale, the *total* range = 0-10

  2. shoulder joint range of motion [ Time Frame: 1 year ]
    abduction measured by goniometer

  3. return to work [ Time Frame: 1 year ]
    duration between return-to-work and operation



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing to sign the inform consent
  • Sufficiently communicate in the Chinese language
  • Be able to follow instructions
  • Newly diagnosed oral cancer
  • Spinal accessory shoulder dysfunction

Exclusion Criteria:

  • Pregnant or breast-feeding woman
  • Cognitively impaired
  • Central nervous disease
  • Distant metastasis or recurrence
  • A history of shoulder pain or known shoulder pathology
  • Unable to communicate or comprehend the questionnaires

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): NCT03545100


Contacts
Contact: Yueh-Hsia Chen, Master +886-3-3281200 ext 2170 yuehhsia@cgmh.org.tw
Contact: Yuan-Hung Chao, PhD +886-2-33668129 yuanhungchao@ntu.edu.tw

Locations
Taiwan
Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Yueh-Hsia Chen, Master    +886-3-3281200 ext 2170    yuehhsia@cgmh.org.tw   
Contact: Yuan-Hung Chao, PhD    +886-2-33668129    yuanhungchao@ntu.edu.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Yueh-Hsia Chen, Master Chang Gung Memorial Hospital

Publications of Results:

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03545100     History of Changes
Other Study ID Numbers: 201800026A3
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chang Gung Memorial Hospital:
oral cancer
shoulder dysfunction
quality of life
motor control
strengthening exercise

Additional relevant MeSH terms:
Mouth Neoplasms
Lip Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Lip Diseases