Head and Neck CancerVITALNCT05988060
Physical Exercise for Patients With Head and Neck Cancer
A study testing Experimental Intervention in people with Head and Neck Cancer, run by Institute Verbeeten at 1 site in Netherlands.
Trial summary
The goal of this trial within cohorts study is to determine and compare physical performance, muscle strength, fatigue, quality of life, body composition, nutritional status, physical activity, treatment tolerability of radiotherapy (RT), chemoradiation (CRT) or bioradiation (BRT), and healthcare related costs in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Experimental Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Nov 2022to 9 Nov 2026
- 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
- patients with HNC who are scheduled for (C/B)RT,
- ≥18 years of age,
- sufficient Dutch writing and reading skills,
- a Karnofsky performance status (KPS) >60,
- able to walk ≥60m without a mobility aid, and
- no contraindication for physical activity as measured with the physical activity readiness questionnaire (PAR-Q).
Who cannot join
- recurrence of HNC and/or
- secondary HNC.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Instituut Verbeeten
Tilburg, North Brabant, 5042 SB
About this study
Official title: The Effect of Physical Exercise During Radiotherapy on Physical Functioning in Patients With Head and Neck Cancer: a Trial Within Cohorts, the VITAL Study
The goal of this trial within cohorts study is to determine and compare physical performance, muscle strength, fatigue, quality of life, body composition, nutritional status, physical activity, treatment tolerability of radiotherapy (RT), chemoradiation (CRT) or bioradiation (BRT), and healthcare related costs in patients with head and neck cancer (HNC) with and without a 10 week physical exercise intervention (PEI) during RT, CRT or BRT ((C/B)RT).
Patients who were randomized in the PEI group and accepted the invitation to undergo the experimental intervention receive a PEI twice a week for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT.
Researchers will compare patients who undergo the PEI with patients who did not undergo the PEI to see if there is difference in physical performance, muscle strength, fatigue, Quality of Life, body composition, nutritional status, physical activity, treatment tolerability of (C/B)RT , and healthcare related costs in patients with Head and Neck Cancer (HNC) with and without a 10 week Physical Exercise Intervention (PEI) during (C/B)RT).
- Conditions
- Head and Neck Cancer
- Being tested
- Experimental Intervention
- Keywords
- head and neck cancer, chemo- or bioradiotherapy, physical exercise intervention, physical performance, trial within cohorts, TwiCs
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental InterventionOther
Also called Physical Exercise Intervention
Patients who were randomized in the PEI group and accepted the invitation to undergo the experimental intervention receive a PEI for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT. The PEI consists of a 60 minutes intervention twice a week and will be supervised by a physiotherapist specialized in oncology.
Patients who receive the intervention also have to do home-based aerobic and muscle strength exercises by themselves three times a week.
| Study group | Role | What they receive |
|---|---|---|
| Patients who were randomized in the PEI group and accepted the invitation | Experimental | The experimental intervention consist of a PEI for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT. Receives: Other: Experimental Intervention |
| Patients who were not randomized in the PEI group | No intervention | Patients will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical performance
six minute walking test
Measured: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Secondary outcomes (12)
Muscle strength
Grip strength
Measured: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Muscle strength
30 seconds chair to stand test
Measured: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Muscle strength
Microfet handheld dynamometer
Measured: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Health Related Quality of Life
Assessed by the EuroQol- five dimensions- five level (EQ-5D-5L). This questionnaire contains 6 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a total score for global health. The first 5 item have 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The score of these item can range from 0 to 4. The higher the total score of these five items, the lower the quality of live. The global health scores on a range 0-100. The higher the score of this item, the higher the global health.
Measured: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Health Related Quality of Life
Assessed by the European organisation for research and treatment for cancer quality of life questionnaire (EORTC QLQ-C30). This questionnaire contains 30 questions scoring 9 subscales and 6 single items: 5 functional scales, 3 symptom scales and 1 global health / quality of life scale. The score of each subscale of single items ranges from 0 to 100. A higher score on the functional scales means a high level of functioning. A higher score on the symptom scales means a high level of experiencing symptoms. A higher score on global health / quality of life means a high score of quality of life.
Measured: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Health Related Quality of Life
Assessed by the European organisation for research and treatment for cancer quality of life questionnaire head and neck module (EORTC-QLQ-H\&N43). This questionnaire contains 43 specific head and neck cancer questions scoring 19 subscales of symptoms. The higher the score of the subscale, the higher the level symptomology.
Measured: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Fatigue
Assessed by the multidimensional fatigue inventory (MFI). The MFI contains 20 items scoring the following domains: general, physical and mental fatigue, and reduced activity and motivation. Every scale scores 4 till 20. The greater the score, the more fatigue or limitations in live because of fatigue.
Measured: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Body composition
body mass index (BMI)
Measured: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Nutrition status
Assessed by the short nutritional assessment questionnaire (SNAQ). The short nutritional assessment questionnaire (SNAQ) consists of three questions and will be used to monitor nutritional status and assess the risk of malnutrition. The total score of this questionnaire ranges from 0 to 7. 0 means no nutritional problems and a high score means malnutrition.
Measured: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Physical activity
Assessed by the short questionnaire to assess health enhancing physical activity (SQUASH). The SQUASH measures the frequency, duration and intensity of 4 different physical activity: physical activity going to work, physical activity during household activity, physical activity at work, physical activity in spare time. The higher the score, the higher the level of physical activity.
Measured: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Tolerability of radiotherapy, chemoradiation or bioradiation
tolerability will be retrieved from medical records and registered as the percentage of scheduled treatment completion, percentage of (C/B)RT adjustment and type of (C/B)RT adjustment.
Measured: M1 (12 weeks), M2 (6 months), M3 (12 months)
socio-demographic data and medical data
age, gender, education, employment, marital status tumour site, disease stage, comorbidity, HPV status, tobacco and alcohol use, nutrition status and type of treatment.
Measured: M0 (baseline/before (C/B)RT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start9 Nov 2022
- Primary completion9 Nov 2025 (estimated)
- Study completion9 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study a TwiCs design will be used. The TwiCs design consists of an experimental intervention study within an observational longitudinal cohort. This design uses a staged-informed consent. Patients will be asked to participate in an observational longitudinal cohort study and will be informed about the design with the probability to be randomly invited for an experimental intervention which they can accept or refuse. When patients are willing to participate in the observational longitudinal cohort, an informed consent (IC) will be signed. Directly after cohort enrollment, all patients will be randomized.
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute Verbeeten
- Sponsor type
- University, hospital or other
- Collaborators
- Verbeeten Fonds, Stichting Fight Cancer, CZ Fonds
- Responsible party
- Sponsor
- Investigators
- Yvette Kriellaars, Msc., Principal investigator, Instituut Verbeeten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988060
- Sponsor's protocol ID
- NL79549.028.21
- Acronym
- VITAL
- Status last verified
- Aug 2023
- First submitted
- 20 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kriellaars Y, Vermaire JA, Beugeling M, Poorter R, Drijvers J, Speksnijder CM. The effect of physical exercise during radiotherapy on physical performance in patients with head and neck cancer: a trial within cohorts study protocol, the vital study. BMC Cancer. 2024 Apr 1;24(1):403. doi: 10.1186/s12885-024-12172-2.
PubMed 38561708
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physical Exercise During Radiotherapy on Physical Functioning in Patients With Head and Neck Cancer: a Trial Within Cohorts, the VITAL Study
- ClinicalTrials.gov ID
- NCT05988060
- Acronym / sponsor ID
- VITAL / NL79549.028.21
- Conditions
- Head and Neck Cancer
- Keywords
- head and neck cancer, chemo- or bioradiotherapy, physical exercise intervention, physical performance, trial within cohorts, TwiCs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Institute VerbeetenUniversity, hospital or other
- Collaborators
- Verbeeten Fonds, Stichting Fight Cancer, CZ Fonds
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 9 Nov 2025 (estimated)
- Study completion
- 9 Nov 2026 (estimated)
- First posted
- 14 Aug 2023 (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 goal of this trial within cohorts study is to determine and compare physical performance, muscle strength, fatigue, quality of life, body composition, nutritional status, physical activity, treatment tolerability of radiotherapy (RT), chemoradiation (CRT) or bioradiation (BRT), and healthcare related costs in patients with head and neck cancer (HNC) with and without a 10 week physical exercise intervention (PEI) during RT, CRT or BRT ((C/B)RT).
Patients who were randomized in the PEI group and accepted the invitation to undergo the experimental intervention receive a PEI twice a week for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT.
Researchers will compare patients who undergo the PEI with patients who did not undergo the PEI to see if there is difference in physical performance, muscle strength, fatigue, Quality of Life, body composition, nutritional status, physical activity, treatment tolerability of (C/B)RT , and healthcare related costs in patients with Head and Neck Cancer (HNC) with and without a 10 week Physical Exercise Intervention (PEI) during (C/B)RT).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this study a TwiCs design will be used. The TwiCs design consists of an experimental intervention study within an observational longitudinal cohort. This design uses a staged-informed consent. Patients will be asked to participate in an observational longitudinal cohort study and will be informed about the design with the probability to be randomly invited for an experimental intervention which they can accept or refuse. When patients are willing to participate in the observational longitudinal cohort, an informed consent (IC) will be signed. Directly after cohort enrollment, all patients will be randomized.
| Arm | Type | Receives |
|---|---|---|
| Patients who were randomized in the PEI group and accepted the invitation | Experimental | Other: Experimental InterventionThe experimental intervention consist of a PEI for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT. |
| Patients who were not randomized in the PEI group | No intervention | –Patients will receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients with HNC who are scheduled for (C/B)RT,
- ≥18 years of age,
- sufficient Dutch writing and reading skills,
- a Karnofsky performance status (KPS) >60,
- able to walk ≥60m without a mobility aid, and
Key exclusion criteria (2 listed)
- recurrence of HNC and/or
- secondary HNC.
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 |
|---|---|---|
| Experimental InterventionAlso: Physical Exercise InterventionPatients who were randomized in the PEI group and accepted the invitation to undergo the experimental intervention receive a PEI for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT. The PEI consists of a 60 minutes intervention twice a week and will be supervised by a physiotherapist specialized in oncology. Patients who receive the intervention also have to do home-based aerobic and muscle strength exercises by themselves three times a week. | Other | Patients who were randomized in the PEI group and accepted the invitation |
Primary outcome
physical performance
Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
six minute walking test
12 secondary outcomes
Muscle strength
Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Muscle strength
Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Muscle strength
Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Health Related Quality of Life
Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Health Related Quality of Life
Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Health Related Quality of Life
Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Fatigue
Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Body composition
Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Nutrition status
Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Physical activity
Time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
Tolerability of radiotherapy, chemoradiation or bioradiation
Time frame: M1 (12 weeks), M2 (6 months), M3 (12 months)
socio-demographic data and medical data
Time frame: M0 (baseline/before (C/B)RT)
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 14 Aug 2023.
- Derived from this study: PubMed 38561708Kriellaars Y, Vermaire JA, Beugeling M, Poorter R, Drijvers J, Speksnijder CM. The effect of physical exercise during radiotherapy on physical performance in patients with head and neck cancer: a trial within cohorts study protocol, the vital study. BMC Cancer. 2024 Apr 1;24(1):403. doi: 10.1186/s12885-024-12172-2.
- Individual participant dataSharing planned: No
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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.
Yvette Kriellaars, Msc. principal investigator
Instituut Verbeeten
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Intervention in people with Head and Neck Cancer, run by Institute Verbeeten at 1 site in Netherlands.
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 6 inclusion and 2 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 14 Aug 2023. 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 Netherlands. 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 Caroline Speksnijder, Dr. (+3188758040, C.M.Speksnijder@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical performance (time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)). 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 NCT05988060, which also lists 1 linked publication.
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 14 Aug 2023.