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Trismus Prevention, Diagnosis and Management: Radiotherapy Planning, Early Detection, and Physical Therapy Intervention

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ClinicalTrials.gov Identifier: NCT02004639
Recruitment Status : Unknown
Verified December 2013 by Far Eastern Memorial Hospital.
Recruitment status was:  Active, not recruiting
First Posted : December 9, 2013
Last Update Posted : December 9, 2013
Sponsor:
Information provided by (Responsible Party):
Far Eastern Memorial Hospital

Brief Summary:
Trismus Prevention, Diagnosis and Management: Radiotherapy Planning, Early detection, and Physical Therapy Intervention

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Radiation: Masticators sparing techniques Other: electro-acupunture treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Taiwan: Institutional Review Board
Study Start Date : March 2013
Estimated Primary Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Mastictors sparing group
Using IMRT or HT to do masticators sparing techniques and physical therapy to prevent trismus.
Radiation: Masticators sparing techniques
No Intervention: Masticators not sparing group
The patients do not receive masticators sparing technique as traditional techniques but still receive physical therapy after radiotherapy to prevent trismus.
Active Comparator: EA group
Using masticators sparing techniques and electro-acupunture stimulation to prevent trismus
Other: electro-acupunture treatment
electro-acupunture treatment and sham-EA

Sham Comparator: Sham-EA group
Using masticators sparing techniques but with sham EA stimulation.
Other: electro-acupunture treatment
electro-acupunture treatment and sham-EA




Primary Outcome Measures :
  1. Time to trismus Progression [ Time Frame: up to 2 years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Head and neck cancer underwent surgery followed by postoperative IMRT or HT with or without chemotherapy

Exclusion Criteria:

Patients treated for recurrent squamous cell carcinomas of the oral cavity (including neck recurrences) are excluded from this analysis. -distance metastasis, previous received radiotherapy or concurrent chemoradation therapy are excluded from this analysis. Patients treated for recurrent squamous cell carcinomas of the oral cavity (including neck recurrences) are excluded from this analysis.


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): NCT02004639


Locations
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Taiwan
Far Eastern Memorial Hospital
New Taipei city, Taiwan, 220
Sponsors and Collaborators
Far Eastern Memorial Hospital

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Responsible Party: Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT02004639     History of Changes
Other Study ID Numbers: FEMH No.101127-F
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: December 9, 2013
Last Verified: December 2013

Keywords provided by Far Eastern Memorial Hospital:
IMRT or HT with chemotherapy

Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site