TrismusOPENNCT03979924
Mouth Opening, Prevention, Education, Nutrition (OPEN)
A study testing Trismus rehabilitation in people with Trismus and Head and Neck Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 6 sites in France.
Trial summary
In France, 11 316 new cases of upper aero-digestive tract cancer were estimated in 2012. These cancers are treated with a triple-therapy combining surgery, radiotherapy and chemotherapy/targeted therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trismus, Head and Neck Cancer
- What is being tested?
- Trismus rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 6 sitesFrance
- Study dates
- 20 Oct 2016to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Epidermoid carcinoma of the buccal cavity, oropharynx or type 1, 2 or 3 carcinoma of cavum according to the WHO classification.
- Radiotherapy (≥ 54Gy in the oropharynx) and concomitant chemotherapy (including targeted therapies) with or without surgery.
- Patients ≥ 18 years old, understanding French.
- Patients who gave their informed consent prior to the study
Who cannot join
- Disease and/or trauma with an effect on jaw mobility with permanent trismus.
- Psychiatric non-stabilized comorbidity.
- Lack of the median and lateral incisors.
- Metastatic patient.
- Legal inability or limited legal capacity.
- Medical or psychological conditions inducing incapacity of the subject to complete the study or give his/her consent.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU d'Amiens
Amiens, 80054
Institut Sainte catherine
Avignon, 84918
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298
ONCOGARD
Nîmes, Gard, 30900
CHU de la Réunion
Saint-Pierre, 97448
About this study
Official title: Trismus Prevalence and Preventive Rehabilitation Associated With Therapeutic Education for Patients With Head and Neck Cancer Treated With Concomitant Radiochemotherapy
In France, 11 316 new cases of upper aero-digestive tract cancer were estimated in 2012. These cancers are treated with a triple-therapy combining surgery, radiotherapy and chemotherapy/targeted therapies. Treatment-induced sequelae are often burdensome: reduction in mouth opening, eventually on to trismus, limitation of lips and tongue mobility, deterioration in oral hygiene, pain due to inflammation and muscle fibrosis. Trismus is defined as a mouth opening of less than 35mm in patients with head and neck cancers. It can be induced by treatments (surgery or radiotherapy) but is also reported at the time of diagnosis, due to the local evolution of the tumour.
Management of trismus and its consequences is currently mostly based on physiotherapy of maxillary constrictions in order to limit or decrease the reduction of mouth opening in these patients. Exercise protocols have been set up and evaluated in the literature, but with various results. The benefit of a physiotherapy intervention on trismus prevalence, mouth opening, and patients' quality of life has not yet been shown.
Read more
Our hypothesis is that at least 30% of patients treated with radiochemotherapy are affected by trismus. According to the nutrition national recommendations in oncology, patients the most at-risk of loco-regional complications are those who receive radiotherapy doses of 54Gy or more in the oropharynx and concomitant chemotherapy.
It is thus essential to provide these patients with an early and preventive management of trismus and its consequences, during the whole duration of the treatment.
Read the detailed description
The management of trismus and its side effects is essentially based on a re-education of maxillary constrictions to limit or reduce the loss of mouth opening in patients. Exercise protocols are in place and have been evaluated in the literature with discordant results. The beneficial effect of a rehabilitation program on the prevalence of trismus, oral opening and quality of life of patients is not yet clearly demonstrated.
Three studies did not show any significant beneficial effect of rehabilitation programs nor on the prevalence of trismus or the quality of life of patients. A 2014 randomized trial showed no benefit from a passive exercise program on trismus prevention and oral opening. Another 2011 study compared 374 patients, a control group and an intervention group following language mobility exercises, rehabilitation supervised by a physiotherapist and specific trismus prevention exercises with the help of a doctor. specific tool (Jaw Trainer) during and after radiotherapy. A third, more recent, randomized study evaluated the effect of a very comprehensive rehabilitation program consisting of a 45-minute session per week of rehabilitation with a physiotherapist, 7 exercises to be performed 5 times a day at home supplemented by chewing. chewing gum 5 times a day. These last two studies nonetheless concluded the importance of carrying out other work on the subject by working on the objectives of the studies, on the tools used, and on the implementation of the exercise program.
Also, an other study cited above does not show a significant difference in mouth opening between the two rehabilitation groups, but analyzes the adhesion and shows that it is significantly higher (59 versus 41 days) in the standard rehabilitation group, less burdensome for patients. Thus, the issue of patient adherence to active rehabilitation is real and essential to take into account in studies assessing the effect of a rehabilitation program on oral opening.
The prevalence of trismus as well as its management in physiotherapy and the effectiveness of a rehabilitation program are not clearly documented in France. Our hypothesis is that currently at least 30% of patients treated by radiochemotherapy are affected by a trismus. According to national oncology nutrition guidelines, the patients most at risk for locoregional complications are those who receive oropharyngeal ≥ 54 Gray radiotherapy doses, plus concomitant chemotherapy.
It seems essential to offer these patients early and preventive management of this symptom and its consequences, throughout the duration of treatment.
This study is all the more relevant as the progress of treatment of upper aero-digestive tract cancers have allowed an improvement in survival rates, with an increase in the number of patients living with sequelae related to treatments.
The major benefit for patients will be a decrease in the loss of mouth opening during and after treatment, with the consequent improvement of the criteria of well-being and quality of life: the resumption of a normal diet, a decrease the duration of artificial nutrition, better oral hygiene, improved speech and the recovery of mimicry. All this in order to accelerate the return to the most normal social and professional life possible.
- Conditions
- Trismus, Head and Neck Cancer
- Being tested
- Trismus rehabilitation
- Keywords
- Trismus, prevention, education, nutrition, preventive rehabilitation, mouth
- Medical subject headings
- Trismus, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trismus rehabilitationBehavioural
The patient will be followed-up by a physiotherapist during all the whole radiotherapy treatment, with short 15-min sessions, twice a week. He/she will be trained to perform regularly and by him/herself the preventive/rehabilitation exercises than the patient will do twice a day until the end of the radiotherapy treatment. The patient will then continue, in an autonomous manner, with his/her rehabilitation.
In case of trismus occurrence, the physiotherapist will advise the patient to add a passive tool to the active exercises (Jaw Trainer, Therabite, tongue depressors,…) in order to strengthen the stretching.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Step | Other | The interventional step will comprise the same follow-up as the observational step, except for the addition of an early and preventive care, conducted by a specialized physiotherapist using an active exercise handbook elaborated with the patient's therapeutic education transversal Unit (Utep). This aims at increasing the patient's adhesion to the program and to limit the reduction of mouth opening and its consequences ( Trismus rehabilitation) Receives: Behavioral: Trismus rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trismus prevalence
The mouth opening is measured by the distance between the upper left median incisive (n°21) and the lower left median incisive (n°31) with the Therabite Range of Motion Scale. Trismus is defined as a mouth opening of less than 35mm.
Measured: 10 weeks after the end of radiochemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start20 Oct 2016
- Primary completion6 Feb 2025
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for TrismusStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- kerstin faravel, Principal investigator, Institut régional du Cancer de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979924
- Sponsor's protocol ID
- ICM-URC 2016-08
- Acronym
- OPEN
- Status last verified
- Feb 2025
- First submitted
- 4 Jun 2019
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Teguh DN, Levendag PC, Voet P, van der Est H, Noever I, de Kruijf W, van Rooij P, Schmitz PI, Heijmen BJ. Trismus in patients with oropharyngeal cancer: relationship with dose in structures of mastication apparatus. Head Neck. 2008 May;30(5):622-30. doi: 10.1002/hed.20760.
PubMed 18213726Rao SD, Saleh ZH, Setton J, Tam M, McBride SM, Riaz N, Deasy JO, Lee NY. Dose-volume factors correlating with trismus following chemoradiation for head and neck cancer. Acta Oncol. 2016;55(1):99-104. doi: 10.3109/0284186X.2015.1037864. Epub 2015 Apr 29.
PubMed 25920361Dijkstra PU, Huisman PM, Roodenburg JL. Criteria for trismus in head and neck oncology. Int J Oral Maxillofac Surg. 2006 Apr;35(4):337-42. doi: 10.1016/j.ijom.2005.08.001. Epub 2005 Nov 8.
PubMed 16280237Placko G, Bellot-Samson V, Brunet S, Guyot L, Richard O, Cheynet F, Chossegros C, Ouaknine M. [Normal mouth opening in the adult French population]. Rev Stomatol Chir Maxillofac. 2005 Nov;106(5):267-71. doi: 10.1016/s0035-1768(05)86038-3. French.
PubMed 16292219Cox SC, Walker DM. Establishing a normal range for mouth opening: its use in screening for oral submucous fibrosis. Br J Oral Maxillofac Surg. 1997 Feb;35(1):40-2. doi: 10.1016/s0266-4356(97)90007-3.
PubMed 9043002van der Molen L, van Rossum MA, Rasch CR, Smeele LE, Hilgers FJ. Two-year results of a prospective preventive swallowing rehabilitation trial in patients treated with chemoradiation for advanced head and neck cancer. Eur Arch Otorhinolaryngol. 2014 May;271(5):1257-70. doi: 10.1007/s00405-013-2640-8. Epub 2013 Jul 28.
PubMed 23892729van der Molen L, van Rossum MA, Burkhead LM, Smeele LE, Hilgers FJ. Functional outcomes and rehabilitation strategies in patients treated with chemoradiotherapy for advanced head and neck cancer: a systematic review. Eur Arch Otorhinolaryngol. 2009 Jun;266(6):889-900. doi: 10.1007/s00405-008-0817-3. Epub 2008 Sep 30.
PubMed 18825400Johnson J, Johansson M, Ryden A, Houltz E, Finizia C. Impact of trismus on health-related quality of life and mental health. Head Neck. 2015 Nov;37(11):1672-9. doi: 10.1002/hed.23816. Epub 2015 Jan 27.
PubMed 24985733Hogdal 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.
PubMed 25229260Buchbinder D, Currivan RB, Kaplan AJ, Urken ML. Mobilization regimens for the prevention of jaw hypomobility in the radiated patient: a comparison of three techniques. J Oral Maxillofac Surg. 1993 Aug;51(8):863-7. doi: 10.1016/s0278-2391(10)80104-1.
PubMed 8336223Pauli N, Fagerberg-Mohlin B, Andrell P, Finizia C. Exercise intervention for the treatment of trismus in head and neck cancer. Acta Oncol. 2014 Apr;53(4):502-9. doi: 10.3109/0284186X.2013.837583. Epub 2013 Oct 31.
PubMed 24175896Scherpenhuizen A, van Waes AM, Janssen LM, Van Cann EM, Stegeman I. The effect of exercise therapy in head and neck cancer patients in the treatment of radiotherapy-induced trismus: A systematic review. Oral Oncol. 2015 Aug;51(8):745-50. doi: 10.1016/j.oraloncology.2015.05.001. Epub 2015 Jun 6.
PubMed 26058916French Speaking Society of Clinical Nutrition and Metabolism (SFNEP). Clinical nutrition guidelines of the French Speaking Society of Clinical Nutrition and Metabolism (SFNEP): Summary of recommendations for adults undergoing non-surgical anticancer treatment. Dig Liver Dis. 2014 Aug;46(8):667-74. doi: 10.1016/j.dld.2014.01.160. Epub 2014 May 1.
PubMed 24794790Friedman AJ, Cosby R, Boyko S, Hatton-Bauer J, Turnbull G. Effective teaching strategies and methods of delivery for patient education: a systematic review and practice guideline recommendations. J Cancer Educ. 2011 Mar;26(1):12-21. doi: 10.1007/s13187-010-0183-x.
PubMed 21161465Faravel K, Jarlier M, Senesse P, Huteau ME, Janiszewski C, Stoebner A, Boisselier P. Response to Somay et al. Letter to the Editor Regarding "Trismus Occurrence and Link With Radiotherapy Doses in Head and Neck Cancer Patients Treated With Chemoradiotherapy". Integr Cancer Ther. 2023 Jan-Dec;22:15347354231167367. doi: 10.1177/15347354231167367. No abstract available.
PubMed 37038637
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trismus Prevalence and Preventive Rehabilitation Associated With Therapeutic Education for Patients With Head and Neck Cancer Treated With Concomitant Radiochemotherapy
- ClinicalTrials.gov ID
- NCT03979924
- Acronym / sponsor ID
- OPEN / ICM-URC 2016-08
- Conditions
- Trismus, Head and Neck Cancer
- Keywords
- Trismus, prevention, education, nutrition, preventive rehabilitation, mouth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 20 Oct 2016 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In France, 11 316 new cases of upper aero-digestive tract cancer were estimated in 2012. These cancers are treated with a triple-therapy combining surgery, radiotherapy and chemotherapy/targeted therapies. Treatment-induced sequelae are often burdensome: reduction in mouth opening, eventually on to trismus, limitation of lips and tongue mobility, deterioration in oral hygiene, pain due to inflammation and muscle fibrosis. Trismus is defined as a mouth opening of less than 35mm in patients with head and neck cancers. It can be induced by treatments (surgery or radiotherapy) but is also reported at the time of diagnosis, due to the local evolution of the tumour.
Management of trismus and its consequences is currently mostly based on physiotherapy of maxillary constrictions in order to limit or decrease the reduction of mouth opening in these patients. Exercise protocols have been set up and evaluated in the literature, but with various results. The benefit of a physiotherapy intervention on trismus prevalence, mouth opening, and patients' quality of life has not yet been shown.
Our hypothesis is that at least 30% of patients treated with radiochemotherapy are affected by trismus. According to the nutrition national recommendations in oncology, patients the most at-risk of loco-regional complications are those who receive radiotherapy doses of 54Gy or more in the oropharynx and concomitant chemotherapy.
It is thus essential to provide these patients with an early and preventive management of trismus and its consequences, during the whole duration of the treatment.
Detailed description
The management of trismus and its side effects is essentially based on a re-education of maxillary constrictions to limit or reduce the loss of mouth opening in patients. Exercise protocols are in place and have been evaluated in the literature with discordant results. The beneficial effect of a rehabilitation program on the prevalence of trismus, oral opening and quality of life of patients is not yet clearly demonstrated.
Three studies did not show any significant beneficial effect of rehabilitation programs nor on the prevalence of trismus or the quality of life of patients. A 2014 randomized trial showed no benefit from a passive exercise program on trismus prevention and oral opening. Another 2011 study compared 374 patients, a control group and an intervention group following language mobility exercises, rehabilitation supervised by a physiotherapist and specific trismus prevention exercises with the help of a doctor. specific tool (Jaw Trainer) during and after radiotherapy. A third, more recent, randomized study evaluated the effect of a very comprehensive rehabilitation program consisting of a 45-minute session per week of rehabilitation with a physiotherapist, 7 exercises to be performed 5 times a day at home supplemented by chewing. chewing gum 5 times a day. These last two studies nonetheless concluded the importance of carrying out other work on the subject by working on the objectives of the studies, on the tools used, and on the implementation of the exercise program.
Also, an other study cited above does not show a significant difference in mouth opening between the two rehabilitation groups, but analyzes the adhesion and shows that it is significantly higher (59 versus 41 days) in the standard rehabilitation group, less burdensome for patients. Thus, the issue of patient adherence to active rehabilitation is real and essential to take into account in studies assessing the effect of a rehabilitation program on oral opening.
The prevalence of trismus as well as its management in physiotherapy and the effectiveness of a rehabilitation program are not clearly documented in France. Our hypothesis is that currently at least 30% of patients treated by radiochemotherapy are affected by a trismus. According to national oncology nutrition guidelines, the patients most at risk for locoregional complications are those who receive oropharyngeal ≥ 54 Gray radiotherapy doses, plus concomitant chemotherapy.
It seems essential to offer these patients early and preventive management of this symptom and its consequences, throughout the duration of treatment.
This study is all the more relevant as the progress of treatment of upper aero-digestive tract cancers have allowed an improvement in survival rates, with an increase in the number of patients living with sequelae related to treatments.
The major benefit for patients will be a decrease in the loss of mouth opening during and after treatment, with the consequent improvement of the criteria of well-being and quality of life: the resumption of a normal diet, a decrease the duration of artificial nutrition, better oral hygiene, improved speech and the recovery of mimicry. All this in order to accelerate the return to the most normal social and professional life possible.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Step | Other | Behavioral: Trismus rehabilitationThe interventional step will comprise the same follow-up as the observational step, except for the addition of an early and preventive care, conducted by a specialized physiotherapist using an active exercise handbook elaborated with the patient's therapeutic education transversal Unit (Utep). This aims at increasing the patient's adhesion to the program and to limit the reduction of mouth opening and its consequences ( Trismus rehabilitation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Epidermoid carcinoma of the buccal cavity, oropharynx or type 1, 2 or 3 carcinoma of cavum according to the WHO classification.
- Radiotherapy (≥ 54Gy in the oropharynx) and concomitant chemotherapy (including targeted therapies) with or without surgery.
- Patients ≥ 18 years old, understanding French.
- Patients who gave their informed consent prior to the study
Key exclusion criteria (6 listed)
- Disease and/or trauma with an effect on jaw mobility with permanent trismus.
- Psychiatric non-stabilized comorbidity.
- Lack of the median and lateral incisors.
- Metastatic patient.
- Legal inability or limited legal capacity.
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 |
|---|---|---|
| Trismus rehabilitationThe patient will be followed-up by a physiotherapist during all the whole radiotherapy treatment, with short 15-min sessions, twice a week. He/she will be trained to perform regularly and by him/herself the preventive/rehabilitation exercises than the patient will do twice a day until the end of the radiotherapy treatment. The patient will then continue, in an autonomous manner, with his/her rehabilitation. In case of trismus occurrence, the physiotherapist will advise the patient to add a passive tool to the active exercises (Jaw Trainer, Therabite, tongue depressors,…) in order to strengthen the stretching. | Behavioural | Interventional Step |
Primary outcome
Trismus prevalence
Time frame: 10 weeks after the end of radiochemotherapy
The mouth opening is measured by the distance between the upper left median incisive (n°21) and the lower left median incisive (n°31) with the Therabite Range of Motion Scale. Trismus is defined as a mouth opening of less than 35mm.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Background: PubMed 18213726Teguh DN, Levendag PC, Voet P, van der Est H, Noever I, de Kruijf W, van Rooij P, Schmitz PI, Heijmen BJ. Trismus in patients with oropharyngeal cancer: relationship with dose in structures of mastication apparatus. Head Neck. 2008 May;30(5):622-30. doi: 10.1002/hed.20760.
- Background: PubMed 25920361Rao SD, Saleh ZH, Setton J, Tam M, McBride SM, Riaz N, Deasy JO, Lee NY. Dose-volume factors correlating with trismus following chemoradiation for head and neck cancer. Acta Oncol. 2016;55(1):99-104. doi: 10.3109/0284186X.2015.1037864. Epub 2015 Apr 29.
- Background: PubMed 16280237Dijkstra PU, Huisman PM, Roodenburg JL. Criteria for trismus in head and neck oncology. Int J Oral Maxillofac Surg. 2006 Apr;35(4):337-42. doi: 10.1016/j.ijom.2005.08.001. Epub 2005 Nov 8.
- Background: PubMed 16292219Placko G, Bellot-Samson V, Brunet S, Guyot L, Richard O, Cheynet F, Chossegros C, Ouaknine M. [Normal mouth opening in the adult French population]. Rev Stomatol Chir Maxillofac. 2005 Nov;106(5):267-71. doi: 10.1016/s0035-1768(05)86038-3. French.
- Background: PubMed 9043002Cox SC, Walker DM. Establishing a normal range for mouth opening: its use in screening for oral submucous fibrosis. Br J Oral Maxillofac Surg. 1997 Feb;35(1):40-2. doi: 10.1016/s0266-4356(97)90007-3.
- Background: PubMed 23892729van der Molen L, van Rossum MA, Rasch CR, Smeele LE, Hilgers FJ. Two-year results of a prospective preventive swallowing rehabilitation trial in patients treated with chemoradiation for advanced head and neck cancer. Eur Arch Otorhinolaryngol. 2014 May;271(5):1257-70. doi: 10.1007/s00405-013-2640-8. Epub 2013 Jul 28.
- Background: PubMed 18825400van der Molen L, van Rossum MA, Burkhead LM, Smeele LE, Hilgers FJ. Functional outcomes and rehabilitation strategies in patients treated with chemoradiotherapy for advanced head and neck cancer: a systematic review. Eur Arch Otorhinolaryngol. 2009 Jun;266(6):889-900. doi: 10.1007/s00405-008-0817-3. Epub 2008 Sep 30.
- Background: PubMed 24985733Johnson J, Johansson M, Ryden A, Houltz E, Finizia C. Impact of trismus on health-related quality of life and mental health. Head Neck. 2015 Nov;37(11):1672-9. doi: 10.1002/hed.23816. Epub 2015 Jan 27.
- Background: PubMed 25229260Hogdal 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.
- Background: PubMed 8336223Buchbinder D, Currivan RB, Kaplan AJ, Urken ML. Mobilization regimens for the prevention of jaw hypomobility in the radiated patient: a comparison of three techniques. J Oral Maxillofac Surg. 1993 Aug;51(8):863-7. doi: 10.1016/s0278-2391(10)80104-1.
- Background: PubMed 24175896Pauli N, Fagerberg-Mohlin B, Andrell P, Finizia C. Exercise intervention for the treatment of trismus in head and neck cancer. Acta Oncol. 2014 Apr;53(4):502-9. doi: 10.3109/0284186X.2013.837583. Epub 2013 Oct 31.
- Background: PubMed 26058916Scherpenhuizen A, van Waes AM, Janssen LM, Van Cann EM, Stegeman I. The effect of exercise therapy in head and neck cancer patients in the treatment of radiotherapy-induced trismus: A systematic review. Oral Oncol. 2015 Aug;51(8):745-50. doi: 10.1016/j.oraloncology.2015.05.001. Epub 2015 Jun 6.
- 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.
kerstin faravel principal investigator
Institut régional du Cancer de Montpellier
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trismus rehabilitation in people with Trismus and Head and Neck Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 6 sites in France.
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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Trismus prevalence (time frame: 10 weeks after the end of radiochemotherapy). 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 NCT03979924, which also lists 16 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 12 Feb 2025.