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Head and Neck NeoplasmHNCNCT04005521

Randomized Study Regarding Preventive Jaw- and Swallowing Intervention for Patients With Head and Neck Cancer

A study testing Preventive intervention in people with Head and Neck Neoplasm and Trismus, run by Sahlgrenska University Hospital at 1 site in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Preventive intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSweden
Study dates
13 Jun 2019to 31 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Sahlgrenska University Hospital

    Gothenburg, 41345

Other trials in Sweden

About this study

Official title: Preventive Randomized Study Regarding Jaw- and Swallowing Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer: the Effect of Preventive Intervention for Trismus, Swallowing Function and Quality of Life

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.

Being tested
Preventive intervention
Medical subject headings
Head and Neck Neoplasms, Trismus, Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preventive interventionBehavioural

    Preventive, structured exercise protocol

Study groups in NCT04005521
Study groupRoleWhat they receive
Preventive interventionExperimentalPatient will perform daily exercise: jaw and swallwing exercises, as well as are encouraged to eat and drink for as long as possible during treatment
Receives: Behavioral: Preventive intervention
Control groupNo interventionNo intervention, only encouragement to eat and drink for as long as possible during treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal Interincisal opening (MIO)

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

    Measured: 1 month post radiotherapy

  2. Swallowing ability

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

    Measured: 1 month after radiotherapy

Secondary outcomes (6)

  1. Trismus and jaw related symptoms

    Patient Reported Outcomes (PRO) measured with Gothenburg Trismus Questionnaire (GTQ). The GTQ consists of 21 items divided into 3 domains; Jaw related problems, Eating limitations and Muscular tension and eight single items concerning facial pain, limitations in mouth opening and inabilities to function on social and working contexts. The GTQ domains range from 0-100 where 0 equals to absence of symtoms and 100 equals worst possible symptoms.

    Measured: Up to 5 years post radiotherapy

  2. Dysphagia related symtoms

    PRO measured with M.D Anderson Dysphagia Inventory (MDADI). This is a cancer-specific instrument measuring dysphagia, social function and quality of life in head and neck cancer patients. It consists of 19 items in four domains; emotional, physical, functional and global quality of life. The range for each subscale is 20-100 where 100 indicates best possible swallowing, i.e. better outcome.

    Measured: Up to 5 years post radiotherapy

  3. Health related quality of life (HRQL)

    Measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) core questionnaire (c30). Consists of 30 items divided into six functional domains (Physical, Role, Cognitive, Emotional, and Social Functioning and Global Quality of life), three symptom scales (Fatigue, Pain, and Nausea/Vomiting) and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). All domains range from 0-100. For the functional domains a higher score indicates good function, while for all other domains a high score indicates a high prevalence of symtoms, i.e. worse HRQL.

    Measured: Up to 5 years post radiotherapy

  4. Health related quality of life (HRQL)

    Measured with the EORTC QLQ Head and neck module (HN35). It consists of 35 questions regarding symptoms more specific to the head and neck cancer population, and domain scores range from 0-100, where a higher score represents the prevalence of more symtoms, i.e. worse HRQL.

    Measured: Up to 5 years post radiotherapy

  5. Swallowing ability

    Swallowing ability measured with FEES

    Measured: Up to 5 years post radiotherapy

  6. Maximal Interincisal opening (MIO)

    Jaw opening measured in millimeters

    Measured: Up to 5 years post radiotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2019
  2. Study start13 Jun 2019
  3. Primary completion31 Jul 2023
  4. Study completion31 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04005521
Sponsor's protocol ID
00
Acronym
HNC
Status last verified
Nov 2024
First submitted
13 Jun 2019
Last updated
2 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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. 2026 Jun;20(3):1145-1156. doi: 10.1007/s11764-024-01717-w. Epub 2024 Nov 22.

    PubMed 39576571

  • 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.

    PubMed 39091121

Questions about this trial

What is this clinical trial studying?

A study testing Preventive intervention in people with Head and Neck Neoplasm and Trismus, run by Sahlgrenska University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal Interincisal opening (MIO) (time frame: 1 month post radiotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04005521, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.

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