Head and Neck NeoplasmsFIT4TREATNCT05418842
Exercise Prehabilitation in Patients With Head and Neck Squamous-cell Carcinoma: The FIT4TREAT Trial
A study testing Prehabilitation in people with Head and Neck Neoplasms, run by Associacao de Investigacao de Cuidados de Suporte em Oncologia at 5 sites in Portugal.
Trial summary
The main purpose of this randomized-controlled trial is to evaluate the effects of prehabilitation based on exercise training (ET) on functional capacity in HNC patients treated with chemoradiotherapy (CRT). Forty-six participants will be randomized (1:1 ratio) into prehabilitation and usual care groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 5 sitesPortugal
- Study dates
- 28 May 2021to 13 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age ≥18 years old;
- Histologically confirmed HNSCC located on the oral cavity, larynx, oropharynx, hypopharynx, nasopharynx or in lymph nodes from an unknown primary tumor (stage I-IV);
- Proposed for concomitant chemoradiotherapy with curative intent;
- Date of treatment beginning ≥2 weeks from baseline assessment;
- ECOG-Performance Status 0-1.
Who cannot join
- Completion of previous anticancer treatment within less than a year;
- Uncontrolled hypertension, cardiac or pulmonary disease;
- Contraindications to exercise training;
- Inability to provide informed consent;
- Expected inability to fulfil the proposed schedule.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Portugal5 sites
University of Aveiro
Aveiro, 3810-193
University of Maia
Maia, Porto District, 4475-690
Instituto Português de Oncologia do Porto (IPO-Porto)
Porto, Região
Liga Portuguesa Contra o Cancro - Núcleo Regional do Norte (LPCC-NRN)
Porto
Centro Hospitalar Vila Nova de Gaia/Espinho
Vila Nova de Gaia, Porto District, 4434-502
About this study
The main purpose of this randomized-controlled trial is to evaluate the effects of prehabilitation based on exercise training (ET) on functional capacity in HNC patients treated with chemoradiotherapy (CRT). Forty-six participants will be randomized (1:1 ratio) into prehabilitation and usual care groups. The length of intervention will be at least 2 weeks. Data will be collected at diagnosis, immediately before anti-cancer treatment start and 4 weeks following CRT. Primary outcome is functional capacity as assessed by the six-minute walk test. Additional measures include muscle strength, endothelial function, arterial stiffness, inflammatory biomarkers, body composition, quality of life, treatment tolerance, compliance to treatment, progression-free survival, and overall survival.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Prehabilitation
- Keywords
- Prehabilitation, Exercise, Head and Neck Cancer
- Medical subject headings
- Head and Neck Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
In addition to usual care, the prehabilitation group will exercise 3 times a week, starting immediately after diagnosis and throughout the pre-treatment period. Each exercise session will encompass 5-min warm-up and 45-min conditioning exercises. Aerobic training will be performed using low-volume high intensity interval training (HIIT). The HIIT duration is 16-24 minutes and it will be performed with 8-12 intervals of high intensity (1 minute) and 8-12 intervals of low intensity (1 minute). High intensity intervals will be set to an external load that represents 85-90% of estimated VO2Peak. In addition, patients will do resistance training at moderate intensity. Patients will complete 2 sets of 12 repetitions of 5 upper and lower body exercises.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation Group | Experimental | In addition to standard medical care, the prehabilitation group will have three supervised exercise training sessions per week from diagnosis to start of radiotherapy (pre-treatment phase). Receives: Other: Prehabilitation |
| Control Group | No intervention | The control group will receive the standard medical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity
Assessed by six-minute walk test.
Measured: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Secondary outcomes (33)
Functional Capacity
Assessed by six-minute walk test.
Measured: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Isometric Handgrip Muscle Strength
Assessed by hand dynamometer.
Measured: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Isometric Handgrip Muscle Strength
Assessed by hand dynamometer.
Measured: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Arterial Stiffness
Assessed by carotid-femoral pulse wave velocity.
Measured: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Arterial Stiffness
Assessed by carotid-femoral pulse wave velocity.
Measured: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Endothelial Function
Assessed by brachial artery dilation to endothelial-dependent stimuli using an ultrasound, according to the recommendations.
Measured: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Endothelial Function
Assessed by brachial artery dilation to endothelial-dependent stimuli using an ultrasound, according to the recommendations.
Measured: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Lower Limb Functionality
Assessed by 30-second sit to stand test.
Measured: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Lower Limb Functionality
Assessed by 30-second sit to stand test.
Measured: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Health-related Quality of Life
Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). This is a patient-reported questionnaire composed of both multi-item scales and single-item measures. These include 5 functional scales, 3 symptom scales, a global health status / QoL scale, and 6 single items. All of the scales and single-item measures range in score from 0 to 100. A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Health-related Quality of Life
Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). This is a patient-reported questionnaire composed of both multi-item scales and single-item measures. These include 5 functional scales, 3 symptom scales, a global health status / QoL scale, and 6 single items. All of the scales and single-item measures range in score from 0 to 100. A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Head and Neck Cancer-specific Quality of Life
Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN43). This is the head and neck cancer specific module that contains 43 questions with 19 symptoms scales. All of the multi-item scales and single-item measures range in score from 0 to 100. A high score represents a high level of symptomatology or problems.
Measured: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Head and Neck Cancer-specific Quality of Life
Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN43). This is the head and neck cancer specific module that contains 43 questions with 19 symptoms scales. All of the multi-item scales and single-item measures range in score from 0 to 100. A high score represents a high level of symptomatology or problems.
Measured: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Body Weight
Assessed by bioelectrical impedance.
Measured: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Body Weight
Assessed by bioelectrical impedance.
Measured: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Body Mass Index
Assessed by participant's weight in kilograms divided by the square of height in meters.
Measured: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Body Mass Index
Assessed by participant's weight in kilograms divided by the square of height in meters.
Measured: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Muscle Mass
Assessed by bioelectrical impedance.
Measured: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Muscle Mass
Assessed by bioelectrical impedance.
Measured: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Percentage of Body Fat
Assessed by bioelectrical impedance.
Measured: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Percentage of Body Fat
Assessed by bioelectrical impedance.
Measured: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
C-Reactive Protein
Measured: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
C-Reactive Protein
Measured: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Albumin
Measured: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Albumin
Measured: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Hemogram
Measured: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Hemogram
Measured: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Unplanned hospital visits
Measured: From baseline to 4 Weeks after last radiotherapy session
Compliance to Chemotherapy
Assessed as the average relative chemotherapy dose-intensity received for the originally planned regimen based on standard formulas.
Measured: Through chemotherapy completion, an average of 7 weeks
Compliance to Radiotherapy
Assessed assessed as the completion of prescribed dose of radiation during the prescribed time frame.
Measured: Through radiotherapy completion, an average of 7 weeks
Treatment-Related Adverse Events
Assessed by CTCAE-vs.5.
Measured: From the beginning of radiotherapy/chemotherapy to 4 Weeks after last radiotherapy session
Progression-Free Survival
Defined as the time from randomization to the occurrence of disease progression or death.
Measured: From baseline to 5 years after diagnosis
Overall Survival
Defined as the time from randomization to death from any cause.
Measured: From baseline to 5 years after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start28 May 2021
- Primary completion27 Mar 2025
- Study completion13 Jun 2025
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 NeoplasmsStudies 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
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associacao de Investigacao de Cuidados de Suporte em Oncologia
- Sponsor type
- University, hospital or other
- Collaborators
- Research Center in Sports Sciences, Health Sciences and Human Development, University Institute of Maia, Aveiro University, Centro Hospitalar de Vila Nova de Gaia/Espinho
- Responsible party
- Sponsor
- Investigators
- Catarina Garcia, Msc, Principal investigator, Research Center of Sports Science Health Science and Human Development - University of Maia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418842
- Sponsor's protocol ID
- F4T
- Acronym
- FIT4TREAT
- Status last verified
- Mar 2026
- First submitted
- 16 May 2022
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Garcia C, Leao I, Pinto D, Rato ND, Campolargo A, Dias I, Monteiro AR, Soares AM, Basto R, Dias E, Vilela E, Teixeira M, Coimbra E, Oliveira P, Amarelo A, Capela A, Viamonte S, Costa H, Joaquim A, Ribeiro F, Alves AJ. Exercise prehabilitation in head and neck cancer patients proposed for definitive chemoradiotherapy: The FIT4TREAT randomized controlled trial. Oral Oncol. 2026 Aug 31;181:108119. doi: 10.1016/j.oraloncology.2026.108119. Online ahead of print.
PubMed 42673774
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Prehabilitation in Patients With Head and Neck Squamous-cell Carcinoma: The FIT4TREAT Trial
- ClinicalTrials.gov ID
- NCT05418842
- Acronym / sponsor ID
- FIT4TREAT / F4T
- Conditions
- Head and Neck Neoplasms
- Keywords
- Prehabilitation, Exercise, Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Associacao de Investigacao de Cuidados de Suporte em OncologiaUniversity, hospital or other
- Collaborators
- Research Center in Sports Sciences, Health Sciences and Human Development, University Institute of Maia, Aveiro University, Centro Hospitalar de Vila Nova de Gaia/Espinho
- Study start
- 28 May 2021 (actual)
- Primary completion
- 27 Mar 2025 (actual)
- Study completion
- 13 Jun 2025 (actual)
- First posted
- 14 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 main purpose of this randomized-controlled trial is to evaluate the effects of prehabilitation based on exercise training (ET) on functional capacity in HNC patients treated with chemoradiotherapy (CRT). Forty-six participants will be randomized (1:1 ratio) into prehabilitation and usual care groups. The length of intervention will be at least 2 weeks. Data will be collected at diagnosis, immediately before anti-cancer treatment start and 4 weeks following CRT. Primary outcome is functional capacity as assessed by the six-minute walk test. Additional measures include muscle strength, endothelial function, arterial stiffness, inflammatory biomarkers, body composition, quality of life, treatment tolerance, compliance to treatment, progression-free survival, and overall survival.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation Group | Experimental | Other: PrehabilitationIn addition to standard medical care, the prehabilitation group will have three supervised exercise training sessions per week from diagnosis to start of radiotherapy (pre-treatment phase). |
| Control Group | No intervention | –The control group will receive the standard medical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years old;
- Histologically confirmed HNSCC located on the oral cavity, larynx, oropharynx, hypopharynx, nasopharynx or in lymph nodes from an unknown primary tumor (stage I-IV);
- Proposed for concomitant chemoradiotherapy with curative intent;
- Date of treatment beginning ≥2 weeks from baseline assessment;
- ECOG-Performance Status 0-1.
Key exclusion criteria (5 listed)
- Completion of previous anticancer treatment within less than a year;
- Uncontrolled hypertension, cardiac or pulmonary disease;
- Contraindications to exercise training;
- Inability to provide informed consent;
- Expected inability to fulfil the proposed schedule.
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 |
|---|---|---|
| PrehabilitationIn addition to usual care, the prehabilitation group will exercise 3 times a week, starting immediately after diagnosis and throughout the pre-treatment period. Each exercise session will encompass 5-min warm-up and 45-min conditioning exercises. Aerobic training will be performed using low-volume high intensity interval training (HIIT). The HIIT duration is 16-24 minutes and it will be performed with 8-12 intervals of high intensity (1 minute) and 8-12 intervals of low intensity (1 minute). High intensity intervals will be set to an external load that represents 85-90% of estimated VO2Peak. In addition, patients will do resistance training at moderate intensity. Patients will complete 2 sets of 12 repetitions of 5 upper and lower body exercises. | Other | Prehabilitation Group |
Primary outcome
Functional Capacity
Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Assessed by six-minute walk test.
33 secondary outcomes
Functional Capacity
Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Isometric Handgrip Muscle Strength
Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Isometric Handgrip Muscle Strength
Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Arterial Stiffness
Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Arterial Stiffness
Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Endothelial Function
Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Endothelial Function
Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Lower Limb Functionality
Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Lower Limb Functionality
Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Health-related Quality of Life
Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Health-related Quality of Life
Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Head and Neck Cancer-specific Quality of Life
Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Head and Neck Cancer-specific Quality of Life
Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Body Weight
Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Body Weight
Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Body Mass Index
Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Body Mass Index
Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Muscle Mass
Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Muscle Mass
Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Percentage of Body Fat
Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Percentage of Body Fat
Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
C-Reactive Protein
Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
C-Reactive Protein
Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Albumin
Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Albumin
Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Hemogram
Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Hemogram
Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Unplanned hospital visits
Time frame: From baseline to 4 Weeks after last radiotherapy session
Compliance to Chemotherapy
Time frame: Through chemotherapy completion, an average of 7 weeks
Compliance to Radiotherapy
Time frame: Through radiotherapy completion, an average of 7 weeks
Treatment-Related Adverse Events
Time frame: From the beginning of radiotherapy/chemotherapy to 4 Weeks after last radiotherapy session
Progression-Free Survival
Time frame: From baseline to 5 years after diagnosis
Overall Survival
Time frame: From baseline to 5 years after diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Derived from this study: PubMed 42673774Garcia C, Leao I, Pinto D, Rato ND, Campolargo A, Dias I, Monteiro AR, Soares AM, Basto R, Dias E, Vilela E, Teixeira M, Coimbra E, Oliveira P, Amarelo A, Capela A, Viamonte S, Costa H, Joaquim A, Ribeiro F, Alves AJ. Exercise prehabilitation in head and neck cancer patients proposed for definitive chemoradiotherapy: The FIT4TREAT randomized controlled trial. Oral Oncol. 2026 Aug 31;181:108119. doi: 10.1016/j.oraloncology.2026.108119. Online ahead of print.
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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. This study is not recruiting at the moment.
Catarina Garcia, Msc principal investigator
Research Center of Sports Science Health Science and Human Development - University of Maia
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Head and Neck Neoplasms, run by Associacao de Investigacao de Cuidados de Suporte em Oncologia at 5 sites in Portugal.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Portugal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional Capacity (time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy). 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 NCT05418842, 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 25 Mar 2026.