NCT03206242

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
1 year until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
Last Updated

July 2, 2017

Status Verified

May 1, 2015

Enrollment Period

1.5 years

First QC Date

February 17, 2015

Last Update Submit

June 30, 2017

Conditions

Head and Neck CancerOral Cancer

Keywords

RehabilitationPhysiotherapyTrismusPainReturn to workQuality of life

Outcome Measures

Primary Outcomes (5)

  • return to work as measured by interview

    1 year

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

    1 year

  • physical functions measured by 6-minute walking test

    1 year

  • quality of life as measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-H&N35

    1 year

  • physical functions measured by time up & go test

    1 year

Secondary Outcomes (5)

  • shoulder function measured by function-related tests

    1 year

  • pain measured by Visual Analog Scale

    1 year

  • mouth opening measured by Boley gauge

    1 year

  • joint range of motion measured by goniometer

    1 year

  • muscle strength measured by manual muscle testing

    1 year

Study Arms (3)

initial

0 month begin physiotherapy

Other: Physiotherapy

3 months after physiotherapy

3 months after physiotherapy

Other: Physiotherapy

6 months after physiotherapy

6 months after physiotherapy

Other: Physiotherapy

Interventions

PhysiotherapyOTHER

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.

Also known as: Rehabilitation
3 months after physiotherapy6 months after physiotherapyinitial

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects receive physical therapy at Linkou Chang Gung Memorial Hospital will be invited to participate this study.

You may qualify if:

  • Clinical diagnosis of oral cancer
  • Post-reconstructive surgery
  • Age between 20 to 65 years old
  • Must be able to follow instructions

You may not qualify if:

  • Central nervous disease
  • Metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Taoyuan District, 333, Taiwan

Location

Related Publications (33)

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    PMID: 20014446RESULT

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    PMID: 24817237RESULT

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    PMID: 20623305RESULT

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    PMID: 22422558RESULT

  • 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.

    PMID: 22864015RESULT

  • 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.

    PMID: 24658376RESULT

  • 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.

    PMID: 24478217RESULT

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    PMID: 21794962RESULT

  • 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.

    PMID: 22108231RESULT

  • 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.

    PMID: 21541945RESULT

  • 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.

    PMID: 12988177RESULT

  • McNeely ML, Parliament MB, Seikaly H, Jha N, Magee DJ, Haykowsky MJ, Courneya KS. Effect of exercise on upper extremity pain and dysfunction in head and neck cancer survivors: a randomized controlled trial. Cancer. 2008 Jul 1;113(1):214-22. doi: 10.1002/cncr.23536.

    PMID: 18457329RESULT

  • Pauli N, Andrell P, Johansson M, Fagerberg-Mohlin B, Finizia C. Treating trismus: A prospective study on effect and compliance to jaw exercise therapy in head and neck cancer. Head Neck. 2015 Dec;37(12):1738-44. doi: 10.1002/hed.23818. Epub 2014 Sep 25.

    PMID: 24986051RESULT

  • Hogdal N, Juhl C, Aadahl M, Gluud C. Early preventive exercises versus usual care does not seem to reduce trismus in patients treated with radiotherapy for cancer in the oral cavity or oropharynx: a randomised clinical trial. Acta Oncol. 2015 Jan;54(1):80-7. doi: 10.3109/0284186X.2014.954677. Epub 2014 Sep 17.

    PMID: 25229260RESULT

  • Shepherd KL, Fisher SE. Prospective evaluation of quality of life in patients with oral and oropharyngeal cancer: from diagnosis to three months post-treatment. Oral Oncol. 2004 Aug;40(7):751-7. doi: 10.1016/j.oraloncology.2004.01.018.

    PMID: 15172646RESULT

  • Schliephake H, Jamil MU. Prospective evaluation of quality of life after oncologic surgery for oral cancer. Int J Oral Maxillofac Surg. 2002 Aug;31(4):427-33. doi: 10.1054/ijom.2001.0194.

    PMID: 12361079RESULT

  • Hidalgo DA. Fibula free flap: a new method of mandible reconstruction. Plast Reconstr Surg. 1989 Jul;84(1):71-9.

    PMID: 2734406RESULT

  • Ling XF, Peng X. What is the price to pay for a free fibula flap? A systematic review of donor-site morbidity following free fibula flap surgery. Plast Reconstr Surg. 2012 Mar;129(3):657-674. doi: 10.1097/PRS.0b013e3182402d9a.

    PMID: 22090247RESULT

  • Chou SW, Liao HT, Yazar S, Lin CH, Lin YC, Wei FC. Assessment of fibula osteoseptocutaneous flap donor-site morbidity using balance and gait test. J Orthop Res. 2009 Apr;27(4):555-60. doi: 10.1002/jor.20687.

    PMID: 18985681RESULT

  • Bartaire E, Mouawad F, Mallet Y, Milet P, El Bedoui S, Ton Van J, Chevalier D, Lefebvre JL. Morphologic assessment of mandibular reconstruction by free fibula flap and donor-site functional impairment in a series of 23 patients. Eur Ann Otorhinolaryngol Head Neck Dis. 2012 Oct;129(5):230-7. doi: 10.1016/j.anorl.2011.06.004. Epub 2012 Oct 15.

    PMID: 23078983RESULT

  • Cooper AF, Hankins M, Rixon L, Eaton E, Grunfeld EA. Distinct work-related, clinical and psychological factors predict return to work following treatment in four different cancer types. Psychooncology. 2013 Mar;22(3):659-67. doi: 10.1002/pon.3049. Epub 2012 Mar 21.

    PMID: 22434715RESULT

  • Ross L, Petersen MA, Johnsen AT, Lundstroem LH, Carlsen K, Groenvold M. Factors associated with Danish cancer patients' return to work. A report from the population-based study 'The Cancer Patient's World'. Cancer Epidemiol. 2012 Apr;36(2):222-9. doi: 10.1016/j.canep.2011.06.001. Epub 2011 Aug 15.

    PMID: 21840283RESULT

  • Yang JL, Lin JJ. Reliability of function-related tests in patients with shoulder pathologies. J Orthop Sports Phys Ther. 2006 Aug;36(8):572-6. doi: 10.2519/jospt.2006.2133.

    PMID: 16915978RESULT

  • Bellet RN, Adams L, Morris NR. The 6-minute walk test in outpatient cardiac rehabilitation: validity, reliability and responsiveness--a systematic review. Physiotherapy. 2012 Dec;98(4):277-86. doi: 10.1016/j.physio.2011.11.003. Epub 2012 May 16.

    PMID: 23122432RESULT

  • Schmidt K, Vogt L, Thiel C, Jager E, Banzer W. Validity of the six-minute walk test in cancer patients. Int J Sports Med. 2013 Jul;34(7):631-6. doi: 10.1055/s-0032-1323746. Epub 2013 Feb 26.

    PMID: 23444095RESULT

  • Ch'ng S, Oates J, Gao K, Foo K, Davies S, Brunner M, Clark JR. Prospective quality of life assessment between treatment groups for oral cavity squamous cell carcinoma. Head Neck. 2014 Jun;36(6):834-40. doi: 10.1002/hed.23387. Epub 2013 Sep 2.

    PMID: 23720248RESULT

  • Canis M, Weiss BG, Ihler F, Hummers-Pradier E, Matthias C, Wolff HA. Quality of life in patients after resection of pT3 lateral tongue carcinoma: Microvascular reconstruction versus primary closure. Head Neck. 2016 Jan;38(1):89-94. doi: 10.1002/hed.23862. Epub 2015 Jun 16.

    PMID: 25224592RESULT

  • Bjordal K, Hammerlid E, Ahlner-Elmqvist M, de Graeff A, Boysen M, Evensen JF, Biorklund A, de Leeuw JR, Fayers PM, Jannert M, Westin T, Kaasa S. Quality of life in head and neck cancer patients: validation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-H&N35. J Clin Oncol. 1999 Mar;17(3):1008-19. doi: 10.1200/JCO.1999.17.3.1008.

    PMID: 10071296RESULT

  • Chie WC, Hong RL, Lai CC, Ting LL, Hsu MM. Quality of life in patients of nasopharyngeal carcinoma: validation of the Taiwan Chinese version of the EORTC QLQ-C30 and the EORTC QLQ-H&N35. Qual Life Res. 2003 Feb;12(1):93-8. doi: 10.1023/a:1022070220328.

    PMID: 12625522RESULT

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    PMID: 10772298RESULT

MeSH Terms

Conditions

Head and Neck NeoplasmsMouth NeoplasmsTrismusPain

Interventions

Physical Therapy ModalitiesRehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesSpasmNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsAftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Yueh-Hsia Chen, Master

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2015

First Posted

July 2, 2017

Study Start

January 1, 2015

Primary Completion

June 30, 2016

Study Completion

June 30, 2016

Last Updated

July 2, 2017

Record last verified: 2015-05

Locations

TW(1)