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Completed

NCT Number: NCT05418842

Exercise Prehabilitation in Patients With Head and Neck Squamous-cell Carcinoma: The FIT4TREAT Trial

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.

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Key information

Conditions

Head and Neck Neoplasms Behavior Motor Activity Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maia, Maia, Porto District, Portugal

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Prehabilitation

Other

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.

Primary outcomes

  1. Functional Capacity

    Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy

    Assessed by six-minute walk test.

Secondary outcomes

  1. Functional Capacity

    Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session

    Assessed by six-minute walk test.

  2. Isometric Handgrip Muscle Strength

    Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy

    Assessed by hand dynamometer.

  3. Isometric Handgrip Muscle Strength

    Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session

    Assessed by hand dynamometer.

  4. Arterial Stiffness

    Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy

    Assessed by carotid-femoral pulse wave velocity.

  5. Arterial Stiffness

    Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session

    Assessed by carotid-femoral pulse wave velocity.

  6. Endothelial Function

    Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy

    Assessed by brachial artery dilation to endothelial-dependent stimuli using an ultrasound, according to the recommendations.

  7. Endothelial Function

    Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session

    Assessed by brachial artery dilation to endothelial-dependent stimuli using an ultrasound, according to the recommendations.

  8. Lower Limb Functionality

    Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy

    Assessed by 30-second sit to stand test.

  9. Lower Limb Functionality

    Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session

    Assessed by 30-second sit to stand test.

  10. Health-related Quality of Life

    Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy

    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.

  11. Health-related Quality of Life

    Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session

    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.

  12. Head and Neck Cancer-specific Quality of Life

    Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy

    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.

  13. 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

    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.

  14. Body Weight

    Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy

    Assessed by bioelectrical impedance.

  15. Body Weight

    Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session

    Assessed by bioelectrical impedance.

  16. Body Mass Index

    Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy

    Assessed by participant's weight in kilograms divided by the square of height in meters.

  17. Body Mass Index

    Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session

    Assessed by participant's weight in kilograms divided by the square of height in meters.

  18. Muscle Mass

    Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy

    Assessed by bioelectrical impedance.

  19. Muscle Mass

    Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session

    Assessed by bioelectrical impedance.

  20. Percentage of Body Fat

    Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy

    Assessed by bioelectrical impedance.

  21. Percentage of Body Fat

    Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session

    Assessed by bioelectrical impedance.

  22. C-Reactive Protein

    Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy

  23. C-Reactive Protein

    Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session

  24. Albumin

    Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy

  25. Albumin

    Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session

  26. Hemogram

    Time frame: Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy

  27. Hemogram

    Time frame: Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session

  28. Unplanned hospital visits

    Time frame: From baseline to 4 Weeks after last radiotherapy session

  29. Compliance to Chemotherapy

    Time frame: Through chemotherapy completion, an average of 7 weeks

    Assessed as the average relative chemotherapy dose-intensity received for the originally planned regimen based on standard formulas.

  30. Compliance to Radiotherapy

    Time frame: Through radiotherapy completion, an average of 7 weeks

    Assessed assessed as the completion of prescribed dose of radiation during the prescribed time frame.

  31. Treatment-Related Adverse Events

    Time frame: From the beginning of radiotherapy/chemotherapy to 4 Weeks after last radiotherapy session

    Assessed by CTCAE-vs.5.

  32. Progression-Free Survival

    Time frame: From baseline to 5 years after diagnosis

    Defined as the time from randomization to the occurrence of disease progression or death.

  33. Overall Survival

    Time frame: From baseline to 5 years after diagnosis

    Defined as the time from randomization to death from any cause.

Sponsors and collaborators

Lead sponsor

Associacao de Investigacao de Cuidados de Suporte em Oncologia

Other

Collaborators

  • Aveiro University
  • Centro Hospitalar de Vila Nova de Gaia/Espinho
  • Research Center in Sports Sciences, Health Sciences and Human Development
  • University Institute of Maia

Registry information

Acronym: FIT4TREAT

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 14, 2022
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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