NCT02004639

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Last Updated

December 9, 2013

Status Verified

December 1, 2013

Enrollment Period

1 year

First QC Date

November 28, 2013

Last Update Submit

December 4, 2013

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

IMRT or HT with chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Time to trismus Progression

    up to 2 years

Study Arms (4)

Mastictors sparing group

ACTIVE COMPARATOR

Using IMRT or HT to do masticators sparing techniques and physical therapy to prevent trismus.

Radiation: Masticators sparing techniques

Masticators not sparing group

NO INTERVENTION

The patients do not receive masticators sparing technique as traditional techniques but still receive physical therapy after radiotherapy to prevent trismus.

EA group

ACTIVE COMPARATOR

Using masticators sparing techniques and electro-acupunture stimulation to prevent trismus

Other: electro-acupunture treatment

Sham-EA group

SHAM COMPARATOR

Using masticators sparing techniques but with sham EA stimulation.

Other: electro-acupunture treatment

Interventions

Masticators sparing techniquesRADIATION
Mastictors sparing group
electro-acupunture treatmentOTHER

electro-acupunture treatment and sham-EA

EA groupSham-EA group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2013

First Posted

December 9, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2014

Last Updated

December 9, 2013

Record last verified: 2013-12

Locations

TW(1)