Head and Neck NeoplasmsNCT05432297
Preventive Physical Activity Intervention in Head and Neck Cancer
A study testing Preventive physical exercise in people with Head and Neck Neoplasms and Physical Inactivity, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 physical activity protocol before and during radiotherapy) or a control… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Physical Inactivity
- What is being tested?
- Preventive physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 2 Jan 2023to Dec 2032
- 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 radiohterapy (+/- chemotherapy) with curative intent
Who cannot join
- Surgery due to head and neck cancer
- Previous treatment for head and neck cancer
- Tracheostomized patients
- Inability to perform exercise intervention
- Inability to perform part of 6-minute walking test
- Inability to independently fill out questionnaires in Swedish
- Previous neurologic or neuromuscular disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, 41345
Lisa Tuomi
About this study
Official title: Preventive Randomized Study Regarding Physical Activity Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer: the Effect of Preventive Intervention for Physical Activity, 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 physical activity protocol before and during radiotherapy) or a control group not performing a specified physical exercise protocol. All patients will be in contact with with a speech language pathologist or a physical therapist weekly during radiotherapy. The study is expected to improve physical function and quality of life during and after oncologic treatment
- Conditions
- Head and Neck Neoplasms, Physical Inactivity
- Being tested
- Preventive physical exercise
- Medical subject headings
- Head and Neck Neoplasms, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventive physical exerciseBehavioural
Daily physical activity depending on daily condition
| Study group | Role | What they receive |
|---|---|---|
| Physical exercise intervention | Experimental | The physical activity intervention is based on national guidelines of physical activity in cancer rehabilitation. A physiotherapist together with each patient will develop individual adaptations to the exercise protocol, with suggestions on which type of exercise the participant is able to perform depending on their daily condition. Suggestions on physical activity for good, bad and in-between-days will be listed in collaboration with the participant, and the participant will report number of minutes/day in each of the 3 physical activity levels stated. Receives: Behavioral: Preventive physical exercise |
| Control | No intervention | The control group will receive general advice on the importance of physical activity during oncologic treatment, according to local clinical standard. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objectively measured physical activity
Measured with an accelerometer. Measures time spent in different activities i minutes/day.
Measured: Up to 12 months
Subjectively measured physical activity - Saltin-Grimby
Measured with the Saltin-Grimby physical activity level scale and the International Physical Activity Questionnaire.
Measured: Up to 12 months
Subjectively measured physical activity (IPAQ)
Measured with the International Physical Activity Questionnaire
Measured: Up to 12 months
Secondary outcomes (8)
Health related quality of life (HRQL) using the EORTC QLQ-C30
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
Health related quality of life (HRQL) using the EORTC QLQ H&N35
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
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
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
Maximal Interincisal opening (MIO)
Jaw opening measured in millimeters
Measured: Up to 5 years post radiotherapy
Body composition
Bioelectric impedance analysis.
Measured: Up to 12 months post radiotherapy
Grip strength
Measured with the a hand dynamometer
Measured: Up to 12 months post radiotherapy
6-minute walking test
Measures total walking distance during 6 minutes.
Measured: Up to 12 months post radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start2 Jan 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Tuomi, Sahlgrenska University Hospital
- Investigators
- Lisa Tuomi, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432297
- Sponsor's protocol ID
- 01
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2022
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Randomized Study Regarding Physical Activity Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer: the Effect of Preventive Intervention for Physical Activity, Function and Quality of Life
- ClinicalTrials.gov ID
- NCT05432297
- Acronym / sponsor ID
- 01
- Conditions
- Head and Neck Neoplasms, Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 physical activity protocol before and during radiotherapy) or a control group not performing a specified physical exercise protocol. All patients will be in contact with with a speech language pathologist or a physical therapist weekly during radiotherapy. The study is expected to improve physical function and quality of life during and after oncologic treatment
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical exercise intervention | Experimental | Behavioral: Preventive physical exerciseThe physical activity intervention is based on national guidelines of physical activity in cancer rehabilitation. A physiotherapist together with each patient will develop individual adaptations to the exercise protocol, with suggestions on which type of exercise the participant is able to perform depending on their daily condition. Suggestions on physical activity for good, bad and in-between-days will be listed in collaboration with the participant, and the participant will report number of minutes/day in each of the 3 physical activity levels stated. |
| Control | No intervention | –The control group will receive general advice on the importance of physical activity during oncologic treatment, according to local clinical standard. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Head and neck cancer (tumors of the oropharynx, pharynx, hypopharynx and larynx)
- Receiving radiohterapy (+/- chemotherapy) with curative intent
Key exclusion criteria (7 listed)
- Surgery due to head and neck cancer
- Previous treatment for head and neck cancer
- Tracheostomized patients
- Inability to perform exercise intervention
- Inability to perform part of 6-minute walking test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preventive physical exerciseDaily physical activity depending on daily condition | Behavioural | Physical exercise intervention |
Primary outcome
Objectively measured physical activity
Time frame: Up to 12 months
Measured with an accelerometer. Measures time spent in different activities i minutes/day.
Subjectively measured physical activity - Saltin-Grimby
Time frame: Up to 12 months
Measured with the Saltin-Grimby physical activity level scale and the International Physical Activity Questionnaire.
Subjectively measured physical activity (IPAQ)
Time frame: Up to 12 months
Measured with the International Physical Activity Questionnaire
8 secondary outcomes
Health related quality of life (HRQL) using the EORTC QLQ-C30
Time frame: Up to 5 years post radiotherapy
Health related quality of life (HRQL) using the EORTC QLQ H&N35
Time frame: Up to 5 years post radiotherapy
Trismus and jaw related symptoms
Time frame: Up to 5 years post radiotherapy
Dysphagia related symtoms
Time frame: Up to 5 years post radiotherapy
Maximal Interincisal opening (MIO)
Time frame: Up to 5 years post radiotherapy
Body composition
Time frame: Up to 12 months post radiotherapy
Grip strength
Time frame: Up to 12 months post radiotherapy
6-minute walking test
Time frame: Up to 12 months post radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Tuomi, PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preventive physical exercise in people with Head and Neck Neoplasms and Physical Inactivity, 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 2 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. 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?
Contact Lisa Tuomi, PhD (+46313421000, tuomi.lisa@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objectively measured physical activity (time frame: Up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2026.