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| Name | Class |
|---|---|
| Research Center in Sports Sciences, Health Sciences and Human Development | OTHER |
| University Institute of Maia | OTHER |
| Aveiro University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Control Group | No Intervention | The control group will receive the standard medical care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Capacity | Assessed by six-minute walk test. | Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Capacity | Assessed by six-minute walk test. | Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session |
| Isometric Handgrip Muscle Strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catarina Garcia, Msc | Research Center of Sports Science Health Science and Human Development - University of Maia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maia | Maia | Porto District | 4475-690 | Portugal | ||
| Centro Hospitalar Vila Nova de Gaia/Espinho |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000082622 | Preoperative Exercise |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Centro Hospitalar de Vila Nova de Gaia/Espinho |
| OTHER |
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|
Assessed by hand dynamometer.
| Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy |
| Isometric Handgrip Muscle Strength | Assessed by hand dynamometer. | 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. | Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy |
| Arterial Stiffness | Assessed by carotid-femoral pulse wave velocity. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session |
| Body Weight | Assessed by bioelectrical impedance. | Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy |
| Body Weight | Assessed by bioelectrical impedance. | 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. | 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. | Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session |
| Muscle Mass | Assessed by bioelectrical impedance. | Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy |
| Muscle Mass | Assessed by bioelectrical impedance. | 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. | Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy |
| Percentage of Body Fat | Assessed by bioelectrical impedance. | Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session |
| 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 | Assessed as the average relative chemotherapy dose-intensity received for the originally planned regimen based on standard formulas. | 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. | Through radiotherapy completion, an average of 7 weeks |
| Treatment-Related Adverse Events | Assessed by CTCAE-vs.5. | 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. | From baseline to 5 years after diagnosis |
| Overall Survival | Defined as the time from randomization to death from any cause. | From baseline to 5 years after diagnosis |
| Vila Nova de Gaia |
| Porto District |
| 4434-502 |
| Portugal |
| Instituto Português de Oncologia do Porto (IPO-Porto) | Porto | Região | Portugal |
| University of Aveiro | Aveiro | 3810-193 | Portugal |
| Liga Portuguesa Contra o Cancro - Núcleo Regional do Norte (LPCC-NRN) | Porto | Portugal |
| D015444 |
| Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |