NCT01733797

Brief Summary

The trial will compare exercises using Therabite® versus wooden spatulas to prevent or relieve trismus in patients with stage 3 and 4 oral/oropharyngeal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

5 active sites

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

First Submitted

Initial submission to the registry

November 19, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

2.7 years

First QC Date

November 19, 2012

Last Update Submit

September 30, 2015

Conditions

Oropharyngeal CancerOral Cancer

Keywords

TrismusTherabiteWooden spatulaHead and Neck cancer

Outcome Measures

Primary Outcomes (1)

  • Change in Jaw measurement

    Willis bite calliper will be used to measure the jaw opening at baseline, 3 and 6 months

    Baseline, 3 months and 6 months at hopsital

Secondary Outcomes (3)

  • Adherence to intervention

    up to 6 months

  • Quality of Life

    Baseline, 3 and 6 months

  • Health economic analysis

    Baseline, 3 and 6 months

Study Arms (2)

Wooden spatula

EXPERIMENTAL
Device: Wooden spatula

Therabite

EXPERIMENTAL
Device: Therabite

Interventions

Wooden spatulaDEVICE

Lollipop sticks placed between incisors

Wooden spatula
TherabiteDEVICE

Hand held device placed in mouth that exercises the jaw

Therabite

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of signed, written informed consent
  • Aged 18 years and older
  • Able to read and write English sufficiently to be able to complete questionnaires
  • Stage 3/4 oral and oropharyngeal cancer patients undergoing:
  • Primary chemoradiotherapy or Surgical free flap plus post operative radiotherapy or post operative chemoradiotherapy
  • All patients will receive 60-70 Gy in 30-35 fractions over 6 to 7 weeks to the region of the pterygoid muscles.
  • All patients will have at least some trismus as indicated by subjective tightening in the jaw.

You may not qualify if:

  • \<12mm mouth opening (cannot use Therabite)
  • Anatomically unable to use Therabite for example patients who may only be partially dentate and to use the Therabite would place extreme stress on the existing teeth
  • Cognitive impairment as judged by the clinicians
  • International patients treated who will not have routine UK follow up.
  • Previous surgery or RT to the head and neck prior to this diagnosis
  • Any patient who has no subjective tightening of the jaw.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

Queen Victoria Hospital

East Grinstead, RH19 3DZ, United Kingdom

Location

Aintree University Hospitals NHS Foundation Trust

Liverpool, L9 7AL, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

York Hospital

York, YO31 8HE, United Kingdom

Location

Related Publications (2)

  • Lee R, Molassiotis A, Rogers SN, Edwards RT, Ryder D, Slevin N. Protocol for the trismus trial-therabite versus wooden spatula in the amelioration of trismus in patients with head and neck cancer: randomised pilot study. BMJ Open. 2018 Mar 30;8(3):e021938. doi: 10.1136/bmjopen-2018-021938.

    PMID: 29602860DERIVED

  • Lee R, Yeo ST, Rogers SN, Caress AL, Molassiotis A, Ryder D, Sanghera P, Lunt C, Scott B, Keeley P, Edwards RT, Slevin N. Randomised feasibility study to compare the use of Therabite(R) with wooden spatulas to relieve and prevent trismus in patients with cancer of the head and neck. Br J Oral Maxillofac Surg. 2018 May;56(4):283-291. doi: 10.1016/j.bjoms.2018.02.012. Epub 2018 Mar 9.

    PMID: 29526341DERIVED

Related Links

MeSH Terms

Conditions

Oropharyngeal NeoplasmsMouth NeoplasmsTrismusHead and Neck Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesMouth DiseasesSpasmNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Prof Slevin

    The Christie NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Trials Project Manager

Study Record Dates

First Submitted

November 19, 2012

First Posted

November 27, 2012

Study Start

December 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 1, 2015

Record last verified: 2015-09

Locations

GB(5)