Relationship Between Mouth Opening and Masseter Elasticity in Oral Cancer

NCT06941727 | Recruiting

• 1 other identifier: 202502031RIN
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to assess the hardness of masticatory muscles in post-surgical oral cancer patients using strain elastography ultrasound, calculating the masseter elasticity index and exploring its association with maximum interincisal mouth opening. Furthermore, the study incorporates exercise training to analyze whether changes in masseter hardness can serve as an objective indicator for predicting the improvement of trismus.

Conditions

Oral Cancer

Keywords

Maximum interincisal opening; Elastography; Masseter muscle; Elasticity

Outcome Measures

Primary Outcomes (2)

• Masseter muscle elasticity

  The masseter elasticity index is calculated as the ratio of the average elasticity of the masseter muscle to that of the isolation-coupling Pad (icPad).

  Pre-intervention, 8 weeks post-intervention

• Maximum interincisal mouth opening

  Maximum interincisal mouth opening is measured using a mouth-opening ruler, placed at the edges of the upper and lower central incisors to determine the distance.

  Pre-intervention, 8 weeks post-intervention

Interventions

ultrasonographic imaging DIAGNOSTIC_TEST

masseter muscle elasticity

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 10 patients, aged 20 to 65 years, are first diagnosed with oral cancer and underwent surgery and routine physical therapy within three months.

You may qualify if:

• Newly diagnosed oral cancer patients who are scheduled to receive cancer-related treatments (e.g., oral cancer surgery, radiotherapy, chemotherapy, or chemoradiotherapy).
• Age between 20 and 65 years.

You may not qualify if:

• Could not communicate.
• Had any disorder that could influence movement performance.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University

Taipei, Taiwan

RECRUITING

Related Publications (8)

• Yeh SA, Tang Y, Lui CC, Huang YJ, Huang EY. Treatment outcomes and late complications of 849 patients with nasopharyngeal carcinoma treated with radiotherapy alone. Int J Radiat Oncol Biol Phys. 2005 Jul 1;62(3):672-9. doi: 10.1016/j.ijrobp.2004.11.002.

  PMID: 15936544 BACKGROUND

• Taljanovic MS, Gimber LH, Becker GW, Latt LD, Klauser AS, Melville DM, Gao L, Witte RS. Shear-Wave Elastography: Basic Physics and Musculoskeletal Applications. Radiographics. 2017 May-Jun;37(3):855-870. doi: 10.1148/rg.2017160116.

  PMID: 28493799 BACKGROUND

• Takashima M, Arai Y, Kawamura A, Hayashi T, Takagi R. Quantitative evaluation of masseter muscle stiffness in patients with temporomandibular disorders using shear wave elastography. J Prosthodont Res. 2017 Oct;61(4):432-438. doi: 10.1016/j.jpor.2017.01.003. Epub 2017 Feb 7.

  PMID: 28188109 BACKGROUND

• Karlsson O, Karlsson T, Pauli N, Andrell P, Finizia C. Jaw exercise therapy for the treatment of trismus in head and neck Cancer: a prospective three-year follow-up study. Support Care Cancer. 2021 Jul;29(7):3793-3800. doi: 10.1007/s00520-020-05517-7. Epub 2020 Nov 24.

  PMID: 32435968 BACKGROUND

• Itoh A, Ueno E, Tohno E, Kamma H, Takahashi H, Shiina T, Yamakawa M, Matsumura T. Breast disease: clinical application of US elastography for diagnosis. Radiology. 2006 May;239(2):341-50. doi: 10.1148/radiol.2391041676. Epub 2006 Feb 16.

  PMID: 16484352 BACKGROUND

• Chen YH, Liang WA, Hsu CY, Guo SL, Lien SH, Tseng HJ, Chao YH. Functional outcomes and quality of life after a 6-month early intervention program for oral cancer survivors: a single-arm clinical trial. PeerJ. 2018 Feb 21;6:e4419. doi: 10.7717/peerj.4419. eCollection 2018.

  PMID: 29492348 BACKGROUND

• Cardoso RC, Kamal M, Zaveri J, Chambers MS, Gunn GB, Fuller CD, Lai SY, Mott FE, McMillan H, Hutcheson KA. Self-Reported Trismus: prevalence, severity and impact on quality of life in oropharyngeal cancer survivorship: a cross-sectional survey report from a comprehensive cancer center. Support Care Cancer. 2021 Apr;29(4):1825-1835. doi: 10.1007/s00520-020-05630-7. Epub 2020 Aug 11.

  PMID: 32779007 BACKGROUND

• Ariji Y, Nakayama M, Nishiyama W, Nozawa M, Ariji E. Shear-wave sonoelastography for assessing masseter muscle hardness in comparison with strain sonoelastography: study with phantoms and healthy volunteers. Dentomaxillofac Radiol. 2016;45(2):20150251. doi: 10.1259/dmfr.20150251. Epub 2015 Dec 1.

  PMID: 26624000 BACKGROUND

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Yueh-Hsia Chen, PhD

  National Taiwan University, College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yueh-Hsia Chen, PhD

CONTACT

+886-2-33668133; yuehhsiachen@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 24, 2025
• Study Start: May 16, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-01

Locations

TW (1)