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AzTrials

Oral CancerNCT03545100

Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors

A study testing regular physical therapy in people with Oral Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Oral Cancer
What is being tested?
regular physical therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTaiwan
Study dates
1 Jun 2018to 6 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

About this study

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.

Read the 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).

Conditions
Oral Cancer
Being tested
motor control therapy, regular physical therapy
Keywords
oral cancer, shoulder dysfunction, quality of life, motor control, strengthening exercise
Medical subject headings
Mouth Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • motor control therapyOther

    scapular muscle progressive resistive exercise(PRE)

  • regular physical therapyOther

    transcutaneous electrical nerve stimulation(TENS), shoulder joint ROM, scapular muscle PRE

Study groups in NCT03545100
Study groupRoleWhat they receive
experimental groupExperimentalmotor control therapy
Receives: Other: motor control therapy; Other: regular physical therapy
control groupActive comparatorregular physical therapy
Receives: Other: regular physical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. shoulder pain

    Visual Analog Scale, the *total* range = 0-10

    Measured: 1 year

  2. shoulder joint range of motion

    abduction measured by goniometer

    Measured: 1 year

  3. shoulder function

    the Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure for upper extremity function

    Measured: 1 year

  4. maximal isometric muscle strength

    measurement for the upper trapezius, middle trapezius, lower trapezius and serrates anterior at the moment of SEMG

    Measured: 1 year

Secondary outcomes (4)

  1. surface electromyography (SEMG)

    measure the muscle activities of the upper trapezius, middle trapezius, lower trapezius and serrates anterior

    Measured: 1 year

  2. quality of life C-30

    European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30

    Measured: 1 year

  3. quality of life H&N35

    European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-H\&N35

    Measured: 1 year

  4. return to work

    duration between return-to-work and operation

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2018
  2. Study start1 Jun 2018
  3. Primary completion6 Feb 2020
  4. Study completion6 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03545100
Sponsor's protocol ID
201800026A3
Status last verified
Aug 2019
First submitted
22 May 2018
Last updated
16 Jul 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wong CH, Wei FC. Microsurgical free flap in head and neck reconstruction. Head Neck. 2010 Sep;32(9):1236-45. doi: 10.1002/hed.21284.

    PubMed 20014446

  • Lutz BS, Wei FC. Microsurgical workhorse flaps in head and neck reconstruction. Clin Plast Surg. 2005 Jul;32(3):421-30, vii. doi: 10.1016/j.cps.2005.02.006.

    PubMed 15979480

  • Neligan PC. Head and neck reconstruction. Plast Reconstr Surg. 2013 Feb;131(2):260e-269e. doi: 10.1097/PRS.0b013e3182778938.

    PubMed 23358022

  • Pauloski BR, Rademaker AW, Logemann JA, Discekici-Harris M, Mittal BB. Comparison of swallowing function after intensity-modulated radiation therapy and conventional radiotherapy for head and neck cancer. Head Neck. 2015 Nov;37(11):1575-82. doi: 10.1002/hed.23796. Epub 2014 Aug 1.

    PubMed 24909649

  • Sheikh A, Shallwani H, Ghaffar S. Postoperative shoulder function after different types of neck dissection in head and neck cancer. Ear Nose Throat J. 2014 Apr-May;93(4-5):E21-6.

    PubMed 24817237

  • van der Molen L, van Rossum MA, Burkhead LM, Smeele LE, Rasch CR, Hilgers FJ. A randomized preventive rehabilitation trial in advanced head and neck cancer patients treated with chemoradiotherapy: feasibility, compliance, and short-term effects. Dysphagia. 2011 Jun;26(2):155-70. doi: 10.1007/s00455-010-9288-y. Epub 2010 Jul 11.

    PubMed 20623305

  • Eades M, Murphy J, Carney S, Amdouni S, Lemoignan J, Jelowicki M, Nadler M, Chasen M, Gagnon B. Effect of an interdisciplinary rehabilitation program on quality of life in patients with head and neck cancer: review of clinical experience. Head Neck. 2013 Mar;35(3):343-9. doi: 10.1002/hed.22972. Epub 2012 Mar 16.

    PubMed 22422558

  • McGarvey AC, Osmotherly PG, Hoffman GR, Chiarelli PE. Impact of neck dissection on scapular muscle function: a case-controlled electromyographic study. Arch Phys Med Rehabil. 2013 Jan;94(1):113-9. doi: 10.1016/j.apmr.2012.07.017. Epub 2012 Aug 1.

    PubMed 22864015

  • Hsieh LC, Chen JW, Wang LY, Tsang YM, Shueng PW, Liao LJ, Lo WC, Lin YC, Tseng CF, Kuo YS, Jhuang JY, Tien HJ, Juan HF, Hsieh CH. Predicting the severity and prognosis of trismus after intensity-modulated radiation therapy for oral cancer patients by magnetic resonance imaging. PLoS One. 2014 Mar 21;9(3):e92561. doi: 10.1371/journal.pone.0092561. eCollection 2014.

    PubMed 24658376

  • Wetzels JW, Merkx MA, de Haan AF, Koole R, Speksnijder CM. Maximum mouth opening and trismus in 143 patients treated for oral cancer: a 1-year prospective study. Head Neck. 2014 Dec;36(12):1754-62. doi: 10.1002/hed.23534. Epub 2014 Jan 30.

    PubMed 24478217

  • Lee R, Slevin N, Musgrove B, Swindell R, Molassiotis A. Prediction of post-treatment trismus in head and neck cancer patients. Br J Oral Maxillofac Surg. 2012 Jun;50(4):328-32. doi: 10.1016/j.bjoms.2011.06.009. Epub 2011 Jul 26.

    PubMed 21794962

  • Stubblefield MD. Radiation fibrosis syndrome: neuromuscular and musculoskeletal complications in cancer survivors. PM R. 2011 Nov;3(11):1041-54. doi: 10.1016/j.pmrj.2011.08.535.

    PubMed 22108231

  • Chan JY, Lua LL, Starmer HH, Sun DQ, Rosenblatt ES, Gourin CG. The relationship between depressive symptoms and initial quality of life and function in head and neck cancer. Laryngoscope. 2011 Jun;121(6):1212-8. doi: 10.1002/lary.21788. Epub 2011 May 3.

    PubMed 21541945

  • EWING MR, MARTIN H. Disability following radical neck dissection; an assessment based on the postoperative evaluation of 100 patients. Cancer. 1952 Sep;5(5):873-83. doi: 10.1002/1097-0142(195209)5:53.0.co;2-4. No abstract available.

    PubMed 12988177

  • Carr SD, Bowyer D, Cox G. Upper limb dysfunction following selective neck dissection: a retrospective questionnaire study. Head Neck. 2009 Jun;31(6):789-92. doi: 10.1002/hed.21018.

    PubMed 19260131

Questions about this trial

What is this clinical trial studying?

A study testing regular physical therapy in people with Oral Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

shoulder pain (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03545100, which also lists 42 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.

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