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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 : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Tracking Information
First Submitted Date  ICMJE May 22, 2018
First Posted Date  ICMJE June 4, 2018
Last Update Posted Date August 30, 2019
Actual Study Start Date  ICMJE June 1, 2018
Estimated Primary Completion Date December 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2019)
  • shoulder pain [ Time Frame: 1 year ]
    Visual Analog Scale, the *total* range = 0-10
  • shoulder joint range of motion [ Time Frame: 1 year ]
    abduction measured by goniometer
  • shoulder function [ Time Frame: 1 year ]
    the Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure for upper extremity function
  • maximal isometric muscle strength [ Time Frame: 1 year ]
    measurement for the upper trapezius, middle trapezius, lower trapezius and serrates anterior at the moment of SEMG
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2018)
  • quality of life [ Time Frame: 1 year ]
    European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30
  • quality of life [ Time Frame: 1 year ]
    European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-H&N35
  • SEMG [ Time Frame: 1 year ]
    European Organization for Research and Treatment of Cancer (EORTC) quality of life surface electromyography
  • shoulder function [ Time Frame: 1 year ]
    the Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure for upper extremity function
Change History Complete list of historical versions of study NCT03545100 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2019)
  • surface electromyography (SEMG) [ Time Frame: 1 year ]
    measure the muscle activities of the upper trapezius, middle trapezius, lower trapezius and serrates anterior
  • quality of life C-30 [ Time Frame: 1 year ]
    European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30
  • 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
  • return to work [ Time Frame: 1 year ]
    duration between return-to-work and operation
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2018)
  • pain [ Time Frame: 1 year ]
    Visual Analog Scale
  • shoulder joint ROM [ Time Frame: 1 year ]
    abduction measured by goniometer
  • return to work [ Time Frame: 1 year ]
    duration between return-to-work and operation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors
Official Title  ICMJE Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Oral Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: experimental group
    motor control therapy
    Interventions:
    • Other: motor control therapy
    • Other: regular physical therapy
  • Active Comparator: control group
    regular physical therapy
    Intervention: Other: regular physical therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 6, 2019
Estimated Primary Completion Date December 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03545100
Other Study ID Numbers  ICMJE 201800026A3
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chang Gung Memorial Hospital
Study Sponsor  ICMJE Chang Gung Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yueh-Hsia Chen, Master Chang Gung Memorial Hospital
PRS Account Chang Gung Memorial Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP