Mouth Opening, Prevention, Education, Nutrition (OPEN)

NCT03979924 | Active Not Recruiting

• 1 other identifier: ICM-URC 2016-08
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 6

Brief 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. 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.

Conditions

Trismus; Head and Neck Cancer

Keywords

Trismus; prevention; education; nutrition; preventive rehabilitation; mouth

Outcome Measures

Primary Outcomes (1)

• 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.

  10 weeks after the end of radiochemotherapy

Study Arms (1)

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)

Behavioral: Trismus rehabilitation

Interventions

Trismus rehabilitation BEHAVIORAL

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.

Interventional Step

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (6)

ONCOGARD

Nîmes, Gard, 30900, France

Location

CHU d'Amiens

Amiens, 80054, France

Location

Institut Sainte catherine

Avignon, 84918, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

CHU de la Réunion

Saint-Pierre, 97448, France

Location

Related Publications (16)

• 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.

  PMID: 18213726 BACKGROUND

• Rao 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.

  PMID: 25920361 BACKGROUND

• Dijkstra 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.

  PMID: 16280237 BACKGROUND

• Placko 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.

  PMID: 16292219 BACKGROUND

• Cox 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.

  PMID: 9043002 BACKGROUND

• van 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.

  PMID: 23892729 BACKGROUND

• van 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.

  PMID: 18825400 BACKGROUND

• Johnson 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.

  PMID: 24985733 BACKGROUND

• Hogdal 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.

  PMID: 25229260 BACKGROUND

• Buchbinder 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.

  PMID: 8336223 BACKGROUND

• Pauli 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.

  PMID: 24175896 BACKGROUND

• Scherpenhuizen 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.

  PMID: 26058916 BACKGROUND

• French 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.

  PMID: 24794790 BACKGROUND

• Friedman 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.

  PMID: 21161465 BACKGROUND

• Faravel 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.

  PMID: 37038637 DERIVED

• Faravel K, Jarlier M, Senesse P, Huteau ME, Janiszewski C, Stoebner A, Boisselier P. Trismus Occurrence and Link With Radiotherapy Doses in Head and Neck Cancer Patients Treated With Chemoradiotherapy. Integr Cancer Ther. 2023 Jan-Dec;22:15347354221147283. doi: 10.1177/15347354221147283.

  PMID: 36625502 DERIVED

MeSH Terms

Conditions

Trismus; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms

Study Officials

• kerstin faravel

  Institut régional du Cancer de Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 7, 2019
• Study Start: October 20, 2016
• Primary Completion: February 6, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)