Clinical trial NCT06148077: Manual Therapy on Oral Opening, Swallow Function and Upper Quarter Mobility on Head and Neck Cancer Survivors
Official title: 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).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Trismus
Dysfunction
Lead sponsor: Universidad de La Frontera
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Trismus has been reported as the second most common comorbidity in survivors of head and neck cancer (HNC). It is mainly associated with post-radiotherapy subcutaneous fibrosis, muscular atrophy, damage to neurological structures in the neck, or a combination of all, affecting masticatory musculature. In addition to this, the loss of flexibility and strength in the shoulder has also been shown to be related to deficits in the function and quality of life of these patients.

The goal of this clinical trial is to determinate the effectiveness and safety of Manual Therapy (MT) on Oral Opening, Swallow Function, as well as the mobility of the upper quarter, the strength of cervical musculature, pain, functionality, and the perception of quality of life in head and neck cancer survivors.

Participants will be assigned randomly to the study groups: a) manual therapy program and control motor exercises and b) motor control exercises (usual care).

The assessment refers to a baseline form (at the beginning of the study), at 6 weeks and at 6 weeks of patient follow-up.

Detailed description: Manual therapy program consists of 3 sessions a week during 6 weeks, with a total of 18 appointments. Measurements are done before starting, after the last intervention and 6 weeks after finishing the treatment.

Eligibility 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.

Primary outcomes:
measure: Maximal mouth opening (MMO)
timeFrame: 6 weeks
measure: Temporomandibular disorders (TMD)
timeFrame: 6 weeks
measure: Swallowing function
timeFrame: 6 weeks
measure: Swallowing difficulty
timeFrame: 6 weeks
measure: Dysphagia
timeFrame: 6 weeks
Secondary outcomes:
measure: Shoulder active range of motion (AROM)
timeFrame: 6 weeks
measure: Cervical active range of motion (AROM)
timeFrame: 6 weeks
measure: Deep cervical flexors endurance
timeFrame: 6 weeks
measure: Muscle Function Test
timeFrame: 6 weeks
measure: Isometric handgrip strength
timeFrame: 6 weeks
measure: Pain Intensity
timeFrame: 6 weeks
measure: Pressure pain thresholds
timeFrame: 6 weeks
measure: Shoulder pain and disability perception
timeFrame: 6 weeks
measure: Health-related quality of life
timeFrame: 6 weeks
measure: Health-related quality of life 2
timeFrame: 6 weeks
measure: Physical Fitness
timeFrame: 6 weeks
measure: Satisfaction with the treatment
timeFrame: 6 weeks
measure: Adverse Events (AE)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Temuco
country: Chile
facility: Barbara Burgos Mansilla
state: Cautin
city: Temuco
country: Chile
facility: Universidad de La Frontera
state: Cautin
Study officials:
affiliation: Universidad de La Frontera
name: Barbara Burgos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wissinger E, Griebsch I, Lungershausen J, Foster T, Pashos CL. The economic burden of head and neck cancer: a systematic literature review. Pharmacoeconomics. 2014 Sep;32(9):865-82. doi: 10.1007/s40273-014-0169-3.
citation: Parke SC, Langelier DM, Cheng JT, Kline-Quiroz C, Stubblefield MD. State of Rehabilitation Research in the Head and Neck Cancer Population: Functional Impact vs. Impairment-Focused Outcomes. Curr Oncol Rep. 2022 Apr;24(4):517-532. doi: 10.1007/s11912-022-01227-x. Epub 2022 Feb 19.
citation: Kamstra JI, Jager-Wittenaar H, Dijkstra PU, Huisman PM, van Oort RP, van der Laan BF, Roodenburg JL. Oral symptoms and functional outcome related to oral and oropharyngeal cancer. Support Care Cancer. 2011 Sep;19(9):1327-33. doi: 10.1007/s00520-010-0952-4. Epub 2010 Aug 13.
citation: McMillan H, Barbon CEA, Cardoso R, Sedory A, Buoy S, Porsche C, Savage K, Mayo L, Hutcheson KA. Manual Therapy for Patients With Radiation-Associated Trismus After Head and Neck Cancer. JAMA Otolaryngol Head Neck Surg. 2022 May 1;148(5):418-425. doi: 10.1001/jamaoto.2022.0082.
citation: Ortiz-Comino L, Martin-Martin L, Galiano-Castillo N, Castro-Martin E, Fernandez-Gualda MA, Lozano-Lozano M, Fernandez-Lao C. The effects of myofascial induction therapy in survivors of head and neck cancer: a randomized, controlled clinical trial. Support Care Cancer. 2022 Dec 17;31(1):49. doi: 10.1007/s00520-022-07482-9.
citation: Castro-Martin E, Galiano-Castillo N, Fernandez-Lao C, Ortiz-Comino L, Postigo-Martin P, Arroyo-Morales M. Myofascial Induction Therapy Improves the Sequelae of Medical Treatment in Head and Neck Cancer Survivors: A Single-Blind, Placebo-Controlled, Randomized Cross-Over Study. J Clin Med. 2021 Oct 27;10(21):5003. doi: 10.3390/jcm10215003.
citation: 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.
citation: Pattanshetty RB, Patil SN. Role of Manual Therapy for Neck Pain and Quality of Life in Head and Neck Cancer Survivors: A Systematic Review. Indian J Palliat Care. 2022 Jan-Mar;28(1):99-112. doi: 10.25259/IJPC_10_2021. Epub 2021 Dec 18.