Oral CancerNCT03875118
Effects of Mouth-opening Training on the Maximum Interincisal Opening
A study testing The mouth-opening training with follow-up telephone calls program and The mouth-opening training without follow-up telephone calls program in people with Oral Cancer, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
PURPOSE:The purpose of the study was to investigate the effect of mouth-opening training with follow-up telephone calls for reducing postoperative trismus in patients with oral cancer. METHODS:The study is a randomized clinical trial using repeated measures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cancer
- What is being tested?
- The mouth-opening training with follow-up telephone calls program and The mouth-opening training without follow-up telephone calls program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Jun 2012to 31 Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 years or older
- diagnosed with oral cancer
- scheduled for a primary curative oral cancer surgery
- able to communicate in Mandarin or Taiwanese
- obtained medical clearance from the patient's attending physician to participate in the study
Who cannot join
- diagnosed with lip or tongue cancers which were less relevant to trismus
- had central incisors extracted during the surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mouth-opening Training With Follow-up Telephone Calls on the Maximum Interincisal Opening and Mandibular Function of Postoperative Oral Cancer Patients: A Randomized Clinical Trial
PURPOSE:The purpose of the study was to investigate the effect of mouth-opening training with follow-up telephone calls for reducing postoperative trismus in patients with oral cancer.
METHODS:The study is a randomized clinical trial using repeated measures. Sixty-eight patients admitted at a general hospital in Taiwan for oral cancer surgery were recruited and randomly assigned to either the intervention or control group. All subjects were instructed to practice mouth-opening exercises three times a day every day for three months. Subjects in the intervention group received additional 6 follow-up phone calls to enhance mouth-opening exercise adherence. Data on maximum interincisal opening and mandibular function impairment were collected before surgery, at one-month, and three-months after discharge, using the TheraBite Range-of-Motion scale and Mandibular Function Impairment Questionnaire.
Read the detailed description
The purpose of the study was to investigate the effect of mouth-opening exercise training with follow-up telephone calls for preventing postoperative trismus in patients with oral cancer. The specific aims were to test the intervention effects on enhancing mouth-opening exercise practice, MIO, and mandibular function. We hypothesized that the intervention group would show 1) better adherence to mouth-opening exercises, 2) greater MIO, and 3) better mandibular function over time, compared to the control group.
The study is a randomized clinical trial using repeated measures. A convenience sample of 68 oral cancer patients was recruited and randomly assigned to either the intervention or control group according to a list generated by the Random Allocation Software. Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence. Data on MIO and mandibular function impairment were collected before surgery, at one-month, and three-months after discharge, using the TheraBite Range-of-Motion scale and the Mandibular Function Impairment Questionnaire. The study was approved by the research ethics committee of the hospital where the data were collected.
All statistical analyses were carried out using the SPSS statistical package version 20.0 (SPSS Inc., Chicago, IL, USA). Characteristics of the subjects were summarized by percentages, means, and standard deviations (SDs). Chi-squared tests or Fisher's exact tests and two independent samples t-tests were used to examine group baseline equivalency. Value changes of study outcomes (MIO and mandibular function impairment) and mouth-opening exercises performed from T1, T2, to T3 were expressed in two study groups. A general linear model was used to model these outcomes as a function of main group effect and main time effect. An interaction term (group difference by time) was added into each model to investigate the synergistic effect of the intervention with time. Both the stability analysis and the analysis of repeated relationships were performed by generalized estimation equations (GEE).
- Conditions
- Oral Cancer
- Being tested
- The mouth-opening training with follow-up telephone calls program, The mouth-opening training without follow-up telephone calls program
- Keywords
- Oral cancer, Trismus, Mouth-opening training, Jaw exercise
- Medical subject headings
- Mouth Neoplasms, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The mouth-opening training with follow-up telephone calls programBehavioural
Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence.
The mouth-opening training without follow-up telephone calls programBehavioural
Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Experimental | Subjects in the intervention group received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence. Receives: Behavioral: The mouth-opening training with follow-up telephone calls program |
| The control group | Active comparator | Subjects in the control group also received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Receives: Behavioral: The mouth-opening training without follow-up telephone calls program |
What is being measured
The primary outcome is the main question the study is designed to answer.
TheraBite Range-of-Motion Scale
The TheraBite® Range-of-Motion Scale was used to measure the maximum incisal opening (MIO), which is the maximal vertical distance between the edges of the incisors of the maxilla and the mandible. The TheraBite® Range-of-Motion Scale is a disposable paper measuring scale specially designed to measure a subject's mouth and jaw opening. The subject sits in an upright position with his mouth open wide. For measuring the vertical opening, the scale has a possible range of 5 to 70 mm, with the notch is placed on the lower incisor midline. The usual range of MIO is between 40 and 55 mm. Subjects with MIO <35 mm are considered to have trismus.
Measured: Change from Baseline to 3 months
Secondary outcomes (1)
Mandibular Function Impairment Questionnaire (MFIQ)
The MFIQ (Mandibular Function Impairment Questionnaire) was used to measure the extent of patients' mandibular function impairment. The questionnaire consists of 17 items, each of which targets a specific oral function impairment; including difficulties in social activity, speech, taking a large bite, chewing hard food, chewing soft food, work and/or daily activities, drinking, laughing, chewing resistant food, yawning, kissing, and eating different types of food. The subjects were asked to indicate how much difficulty they had with each activity or with eating each type of food using a 5-point Likert scale (0 = no difficulty, 4 = very difficult or impossible without help). The total score of the 17 items divided by 68 provides the scale score, with a possible range of 0 to 1. A higher score indicates greater severity of the mandibular function impairment. A score ≤ 0.3, between 0.3 and 0.6, and >0.6 indicates mild, moderate, and severe mandibular function impairment, respectively.
Measured: Change from Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start18 Jun 2012
- Primary completion31 Mar 2014
- Study completion31 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Yuan's General Hospital
- Responsible party
- Principal investigator, Tsae Jyy, Wang, National Taipei University of Nursing and Health Sciences
- Investigators
- Tsae Jyy Wang, PhD, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875118
- Sponsor's protocol ID
- 20110818B
- Status last verified
- Apr 2021
- First submitted
- 13 Mar 2019
- Last updated
- 27 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 24478217Kamstra JI, van Leeuwen M, Roodenburg JLN, Dijkstra PU. Exercise therapy for trismus secondary to head and neck cancer: A systematic review. Head Neck. 2017 Nov;39(11):2352-2362. doi: 10.1002/hed.24859. Epub 2017 Jul 14.
PubMed 29044879Chen M, Li P, Lin F. Influence of structured telephone follow-up on patient compliance with rehabilitation after total knee arthroplasty. Patient Prefer Adherence. 2016 Mar 3;10:257-64. doi: 10.2147/PPA.S102156. eCollection 2016.
PubMed 27042020Agarwal P, Shiva Kumar HR, Rai KK. Trismus in oral cancer patients undergoing surgery and radiotherapy. J Oral Biol Craniofac Res. 2016 Nov;6(Suppl 1):S9-S13. doi: 10.1016/j.jobcr.2016.10.004. Epub 2016 Oct 22.
PubMed 27900243
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mouth-opening Training With Follow-up Telephone Calls on the Maximum Interincisal Opening and Mandibular Function of Postoperative Oral Cancer Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03875118
- Acronym / sponsor ID
- 20110818B
- Conditions
- Oral Cancer
- Keywords
- Oral cancer, Trismus, Mouth-opening training, Jaw exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Collaborators
- Yuan's General Hospital
- Study start
- 18 Jun 2012 (actual)
- Primary completion
- 31 Mar 2014 (actual)
- Study completion
- 31 Mar 2014 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Posted 27 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PURPOSE:The purpose of the study was to investigate the effect of mouth-opening training with follow-up telephone calls for reducing postoperative trismus in patients with oral cancer.
METHODS:The study is a randomized clinical trial using repeated measures. Sixty-eight patients admitted at a general hospital in Taiwan for oral cancer surgery were recruited and randomly assigned to either the intervention or control group. All subjects were instructed to practice mouth-opening exercises three times a day every day for three months. Subjects in the intervention group received additional 6 follow-up phone calls to enhance mouth-opening exercise adherence. Data on maximum interincisal opening and mandibular function impairment were collected before surgery, at one-month, and three-months after discharge, using the TheraBite Range-of-Motion scale and Mandibular Function Impairment Questionnaire.
Detailed description
The purpose of the study was to investigate the effect of mouth-opening exercise training with follow-up telephone calls for preventing postoperative trismus in patients with oral cancer. The specific aims were to test the intervention effects on enhancing mouth-opening exercise practice, MIO, and mandibular function. We hypothesized that the intervention group would show 1) better adherence to mouth-opening exercises, 2) greater MIO, and 3) better mandibular function over time, compared to the control group.
The study is a randomized clinical trial using repeated measures. A convenience sample of 68 oral cancer patients was recruited and randomly assigned to either the intervention or control group according to a list generated by the Random Allocation Software. Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence. Data on MIO and mandibular function impairment were collected before surgery, at one-month, and three-months after discharge, using the TheraBite Range-of-Motion scale and the Mandibular Function Impairment Questionnaire. The study was approved by the research ethics committee of the hospital where the data were collected.
All statistical analyses were carried out using the SPSS statistical package version 20.0 (SPSS Inc., Chicago, IL, USA). Characteristics of the subjects were summarized by percentages, means, and standard deviations (SDs). Chi-squared tests or Fisher's exact tests and two independent samples t-tests were used to examine group baseline equivalency. Value changes of study outcomes (MIO and mandibular function impairment) and mouth-opening exercises performed from T1, T2, to T3 were expressed in two study groups. A general linear model was used to model these outcomes as a function of main group effect and main time effect. An interaction term (group difference by time) was added into each model to investigate the synergistic effect of the intervention with time. Both the stability analysis and the analysis of repeated relationships were performed by generalized estimation equations (GEE).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Behavioral: The mouth-opening training with follow-up telephone calls programSubjects in the intervention group received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence. |
| The control group | Active comparator | Behavioral: The mouth-opening training without follow-up telephone calls programSubjects in the control group also received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 18 years or older
- diagnosed with oral cancer
- scheduled for a primary curative oral cancer surgery
- able to communicate in Mandarin or Taiwanese
- obtained medical clearance from the patient's attending physician to participate in the study
Key exclusion criteria (2 listed)
- diagnosed with lip or tongue cancers which were less relevant to trismus
- had central incisors extracted during the surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The mouth-opening training with follow-up telephone calls programSubjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence. | Behavioural | The intervention group |
| The mouth-opening training without follow-up telephone calls programSubjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. | Behavioural | The control group |
Primary outcome
TheraBite Range-of-Motion Scale
Time frame: Change from Baseline to 3 months
The TheraBite® Range-of-Motion Scale was used to measure the maximum incisal opening (MIO), which is the maximal vertical distance between the edges of the incisors of the maxilla and the mandible. The TheraBite® Range-of-Motion Scale is a disposable paper measuring scale specially designed to measure a subject's mouth and jaw opening. The subject sits in an upright position with his mouth open wide. For measuring the vertical opening, the scale has a possible range of 5 to 70 mm, with the notch is placed on the lower incisor midline. The usual range of MIO is between 40 and 55 mm. Subjects with MIO <35 mm are considered to have trismus.
1 secondary outcome
Mandibular Function Impairment Questionnaire (MFIQ)
Time frame: Change from Baseline to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24478217Wetzels 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.
- Background: PubMed 29044879Kamstra JI, van Leeuwen M, Roodenburg JLN, Dijkstra PU. Exercise therapy for trismus secondary to head and neck cancer: A systematic review. Head Neck. 2017 Nov;39(11):2352-2362. doi: 10.1002/hed.24859. Epub 2017 Jul 14.
- Background: PubMed 27042020Chen M, Li P, Lin F. Influence of structured telephone follow-up on patient compliance with rehabilitation after total knee arthroplasty. Patient Prefer Adherence. 2016 Mar 3;10:257-64. doi: 10.2147/PPA.S102156. eCollection 2016.
- Background: PubMed 27900243Agarwal P, Shiva Kumar HR, Rai KK. Trismus in oral cancer patients undergoing surgery and radiotherapy. J Oral Biol Craniofac Res. 2016 Nov;6(Suppl 1):S9-S13. doi: 10.1016/j.jobcr.2016.10.004. Epub 2016 Oct 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsae Jyy Wang, PhD principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The mouth-opening training with follow-up telephone calls program and The mouth-opening training without follow-up telephone calls program in people with Oral Cancer, run by National Taipei University of Nursing and Health Sciences 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 2 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 27 Apr 2021. 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?
Yes. Results are posted in the registry (first posted 27 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
TheraBite Range-of-Motion Scale (time frame: Change from Baseline to 3 months). 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 NCT03875118, which also lists 4 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 27 Apr 2021.