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THE EFFECTS OF PREVENTION TRISMUS PROGRAM IN PATIENTS WITH HEAD AND NECK CANCER POST-TREATMENT WITH CCRT: A RANDOMIZED CONTROL TRIAL

THE EFFECTS OF PREVENTION TRISMUS PROGRAM IN PATIENTS WITH HEAD AND NECK CANCER POST-TREATMENT WITH CCRT: A RANDOMIZED CONTROL TRIAL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250904006
Enrollment
140
Registered
2025-09-04
Start date
2025-08-27
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and neck cancer (HNC) post-treatment with Concurrent chemoradiotherapy (CCRT) TRISMUS / CCRT / HEAD AND NECK CANCER / INDIVIDUAL AND SELF-MANAGEMENT/JAW EXERCISE ADHERENCE

Interventions

The intervention group receives usual care plus the prevention of trismus program. The trismus program includes providing Knowledge and practice through booklets, video media, return demonstrations, a
Experimental Behavioral,Experimental Behavioral
Intervention group,Control group

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patient HNC has aged over 18 years; the patients who are 60 years and older will be assessed for cognitive impairment using the MINI COG test and score at least 3 points 2. Diagnosis of head and neck cancer patients and staging with stages 3 and 4 using the TNM staging system, 3. Treated with CCRT (all prescribed a dose of 60 to 70 Gy in 30 to 35 fractions to the jaw over 6 to 8 weeks) 4. Baseline MIO less than 35 mm, 5. Eastern Cooperative Oncology Group (ECOG) Performance Status equal to 0 to 2, 6. Ability to read, write, and speak in the Thai language. The family caregivers include 1. Aged over 20 years, the patients who are 60 years and older will be assessed for cognitive impairment using the MINI COG test and score at least 3 points., And 1. The family caregiver lives in the same house for at least 6 months as the significant person involved in daily caregiving, 3. Caring for a patient with a diagnosis of head and neck cancer receiving CCRT from the beginning, taking the role of the main caregiver, being responsible for overseeing the patient's diet and medicines, and bringing the patient for follow-up visits 4. Able to use a mobile phone to process or line applications and have internet access.

Exclusion criteria

Exclusion criteria: The exclusion criteria for patients include 1. A head and neck cancer patient who was diagnosed with hypopharynx and larynx 2. Had another severe illness or co-morbidities requiring hospitalization,3. Motor sequelae affecting the face or neck region, whether secondary to stroke, facial palsy, or trauma.,4. History of surgical interventions involving resection of the mandible,5. Palliative patient, 6. Cognitive impairments as judged by the clinicians. The exclusion criteria for family caregivers: 1. Moving out of the province, 2. Unable to participate throughout the program

Design outcomes

Primary

MeasureTime frame
The effect of the prevention trismus program plus usual care in HNC patients after post treatment with CCRT compared to usual care at 12 weeks at 12 weeks after end of the intervention Incident of trismus

Secondary

MeasureTime frame
Maximum interincisal opening, Mandibular function, Health education impact, and, Adherence of prevention of trismus Measure after post-treatment with CCRT compared between the intervention group and control group at baseline, 4 weeks, and 12 weeks TheraBite range of motion scale, The Gothenburg trismus questionnaire 2, The Health Education Impacts Questionnaires (hei Q), and a self-reported practice diary to measure jaw exercise adherence

Countries

Thailand

Contacts

Public ContactNatthaya Chabuakam

Mahidol university

natthaya@bcnsp.ac.th022010174

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026