Exercise Prehabilitation in Patients With Head and Neck Squamous-cell Carcinoma: The FIT4TREAT Trial
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Prehabilitation Group 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). |
Other: Prehabilitation
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 16-20 minutes and it will be performed with 8-10 intervals of high intensity (1 minute) and 8-10 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.
|
| No Intervention: Control Group The control group will receive the standard medical care. |
Outcome Measures
Primary Outcome Measures
- Functional Capacity [Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy]
Assessed by six-minute walk test.
Secondary Outcome Measures
- Functional Capacity [Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session]
Assessed by six-minute walk test.
- Isometric Handgrip Muscle Strength [Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy]
Assessed by hand dynamometer.
- Isometric Handgrip Muscle Strength [Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session]
Assessed by hand dynamometer.
- Arterial Stiffness [Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy]
Assessed by carotid-femoral pulse wave velocity.
- Arterial Stiffness [Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session]
Assessed by carotid-femoral pulse wave velocity.
- Endothelial Function [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.
- Endothelial Function [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.
- Lower Limb Functionality [Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy]
Assessed by 30-second sit to stand test.
- Lower Limb Functionality [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.
- Health-related Quality of Life [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.
- Health-related Quality of Life [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.
- Head and Neck Cancer-specific Quality of Life [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.
- Head and Neck Cancer-specific Quality of Life [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.
- Body Weight [Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy]
Assessed by bioelectrical impedance.
- Body Weight [Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session]
Assessed by bioelectrical impedance.
- Body Mass Index [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.
- Body Mass Index [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.
- Muscle Mass [Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy]
Assessed by bioelectrical impedance.
- Muscle Mass [Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session]
Assessed by bioelectrical impedance.
- Percentage of Body Fat [Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy]
Assessed by bioelectrical impedance.
- Percentage of Body Fat [Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session]
Assessed by bioelectrical impedance.
- C-Reactive Protein [Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy]
- C-Reactive Protein [Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session]
- Albumin [Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy]
- Albumin [Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session]
- Hemogram [Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy]
- Hemogram [Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session]
- Unplanned hospital visits [From baseline to 4 Weeks after last radiotherapy session]
- Compliance to Chemotherapy [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.
- Compliance to Radiotherapy [Through radiotherapy completion, an average of 7 weeks]
Assessed assessed as the completion of prescribed dose of radiation during the prescribed time frame.
- Treatment-Related Adverse Events [From the beginning of radiotherapy/chemotherapy to 4 Weeks after last radiotherapy session]
Assessed by CTCAE-vs.5.
- Progression-Free Survival [From baseline to 5 years after diagnosis]
Defined as the time from randomization to the occurrence of disease progression or death.
- Overall Survival [From baseline to 5 years after diagnosis]
Defined as the time from randomization to death from any cause.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥18 years old;
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Histologically confirmed HNSCC located on the oral cavity, larynx, oropharynx, hypopharynx, nasopharynx or in lymph nodes from an unknown primary tumor (stage I-IV);
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Proposed for concomitant chemoradiotherapy with curative intent;
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Date of treatment beginning ≥2 weeks from baseline assessment;
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ECOG-Performance Status 0-1.
Exclusion Criteria:
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Completion of previous anticancer treatment within less than a year;
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Uncontrolled hypertension, cardiac or pulmonary disease;
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Contraindications to exercise training;
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Inability to provide informed consent;
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Expected inability to fulfil the proposed schedule.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Maia | Maia | Porto | Portugal | 4475-690 |
| 2 | Centro Hospitalar Vila Nova de Gaia/Espinho | Vila Nova De Gaia | Porto | Portugal | 4434-502 |
| 3 | Instituto Português de Oncologia do Porto (IPO-Porto) | Porto | Região | Portugal | |
| 4 | University of Aveiro | Aveiro | Portugal | 3810-193 | |
| 5 | Liga Portuguesa Contra o Cancro - Núcleo Regional do Norte (LPCC-NRN) | Porto | Portugal |
Sponsors and Collaborators
- Associacao de Investigacao de Cuidados de Suporte em Oncologia
- Research Center in Sports Sciences, Health Sciences and Human Development
- University Institute of Maia
- Aveiro University
- Centro Hospitalar de Vila Nova de Gaia/Espinho
Investigators
- Principal Investigator: Catarina Garcia, Msc, Research Center of Sports Science Health Science and Human Development - University of Maia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- F4T