Manual therapy for improving oral and swallowing function in head and neck cancer survivors
Effects of Manual Therapy on Oral Opening, Swallow Function, and Upper Quarter Mobility in Chilean Survivors of Head and Neck Cancer: A Study Protocol for a Controlled, Randomized Study (MATEO Study, MAnual ThErapy for Oral Opening).
This study is testing if a hands-on therapy program can help survivors of head and neck cancer improve their ability to open their mouths, swallow, and move their upper bodies better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad de La Frontera Academic / other |
| Locations | 2 sites (Temuco, Cautin and 1 other locations) |
| Trial ID | NCT06148077 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness and safety of a manual therapy program on oral opening, swallowing function, and upper quarter mobility in survivors of head and neck cancer. Participants will be randomly assigned to either a manual therapy group or a control group receiving motor control exercises. The intervention consists of three sessions per week over six weeks, totaling 18 appointments, with assessments conducted at baseline, post-intervention, and six weeks after treatment completion. The study focuses on improving quality of life, pain management, and functionality in this patient population.
Who should consider this trial
Good fit: Ideal candidates include Spanish-speaking adults over 18 years old who have undergone oncological treatment for head and neck cancer and have a diagnosis of trismus or related dysfunction.
Not a fit: Patients with active cancer, severe cervical spine issues, or those who have had a stroke may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the quality of life and functional abilities of head and neck cancer survivors suffering from trismus and related dysfunctions.
How similar studies have performed: While there is limited data on manual therapy specifically for this population, similar approaches in physical rehabilitation have shown promise in improving outcomes for cancer survivors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * individuals with HNC * individuals over 18 years of age * individuals who have undergone oncological surgery of the head and neck and/or radiotherapy * having finished oncological medical treatment between 3 and 36 months before inclusion * having a medical diagnosis of trismus and/or TMD and/or cervical or shoulder dysfunction * Spanish native speakers Exclusion Criteria: * sequelae of previous stroke * structural instability and/or osteoporosis of the cervical spine, spondylosis, cervical herniated discs * active osteoradionecrosis or open wounds (fistulas, soft tissue necrosis) in the anatomical treatment area * tracheostomized individuals * metastasis or active cancer * refuse to participate.
Where this trial is running
Temuco, Cautin and 1 other locations
- Barbara Burgos Mansilla — Temuco, Cautin, Chile (Recruiting)
- Universidad de La Frontera — Temuco, Cautin, Chile (Recruiting)
Study contacts
- Principal investigator: Barbara Burgos, PhD — Universidad de La Frontera
- Study coordinator: Barbara Burgos, PhD
- Email: barbara.burgos@ufrontera.cl
- Phone: +56991358814
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.