NCT04005521

Brief Summary

The study includes patients with tumors of the oropharynx, larynx and hypopharynx scheduled to receive radiotherapy with curative intent (+/- chemotherapy). The patients will be randomized into either an intervention group (performing a preventive jaw- and swallowing exercise protocol before and during radiotherapy) or a control group no performing a exercise protocol. All patients will be encouraged to eat or drink for as long as possible during the therapy. All patients will meet with a speech-language therapist weekly during radiotherapy.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
27mo left

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jun 2019Jul 2028

First Submitted

Initial submission to the registry

June 13, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

June 13, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Expected
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

4.1 years

First QC Date

June 13, 2019

Last Update Submit

November 27, 2024

Conditions

Head and Neck NeoplasmTrismusDeglutition Disorders

Outcome Measures

Primary Outcomes (2)

  • Maximal Interincisal opening (MIO)

    Jaw opening measured in millimeters. A MIO \<36 mm is considered as trismus. i.e. limited jaw-opening.

    1 month post radiotherapy

  • Swallowing ability

    Swallowing ability measured with Functional Endoscopic Examination of Swallowing (FEES)

    1 month after radiotherapy

Secondary Outcomes (6)

  • Trismus and jaw related symptoms

    Up to 5 years post radiotherapy

  • Dysphagia related symtoms

    Up to 5 years post radiotherapy

  • Health related quality of life (HRQL)

    Up to 5 years post radiotherapy

  • Health related quality of life (HRQL)

    Up to 5 years post radiotherapy

  • Swallowing ability

    Up to 5 years post radiotherapy

  • +1 more secondary outcomes

Other Outcomes (4)

  • Cost

    Up to 5 years post radiotherapy

  • Quality of life for cost-effectiveness analysis

    Up to 5 years post radiotherapy

  • Quality Adjusted Life Years (QALY)

    Up to 5 years post radiotherapy

  • +1 more other outcomes

Study Arms (2)

Preventive intervention

EXPERIMENTAL

Patient will perform daily exercise: jaw and swallwing exercises, as well as are encouraged to eat and drink for as long as possible during treatment

Behavioral: Preventive intervention

Control group

NO INTERVENTION

No intervention, only encouragement to eat and drink for as long as possible during treatment

Interventions

Preventive interventionBEHAVIORAL

Preventive, structured exercise protocol

Preventive intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Head and neck cancer (tumors of the oropharynx, pharynx, hypopharynx and larynx)
  • Receiving radiohterpay (+/- chemotherapy) with curative intent
  • No previous trismus or dysphagia

You may not qualify if:

  • Surgery due to head and neck cancer
  • Previous treatment for head and neck cancer
  • Tracheostomized patients
  • No teeth
  • Inability to perform exercise intervention
  • Inability to independently fill out questionnaires in Swedish
  • Previous neurologic or neuromuscular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Related Publications (2)

  • Saghafi E, Kadhim K, Andas CA, Cahlin BJ, Finizia C, Axelsson T, Kjeller G, Tuomi L. Jaw exercise in head and neck cancer patients for prevention of temporomandibular disorders: a randomized controlled trial. J Cancer Surviv. 2024 Nov 22. doi: 10.1007/s11764-024-01717-w. Online ahead of print.

    PMID: 39576571BACKGROUND

  • Petersson K, Finizia C, Pauli N, Tuomi L. Preventing radiation-induced dysphagia and trismus in head and neck cancer-A randomized controlled trial. Head Neck. 2025 Jan;47(1):159-174. doi: 10.1002/hed.27886. Epub 2024 Aug 1.

    PMID: 39091121BACKGROUND

MeSH Terms

Conditions

Head and Neck NeoplasmsTrismusDeglutition Disorders

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSpasmNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 13, 2019

First Posted

July 2, 2019

Study Start

June 13, 2019

Primary Completion

July 31, 2023

Study Completion (Estimated)

July 31, 2028

Last Updated

December 2, 2024

Record last verified: 2024-11

Locations

SE(1)