Head and Neck Neoplasms
Conditions
Keywords
Prehabilitation, Exercise, Head and Neck Cancer
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.
Interventions
OTHERPrehabilitation
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.
Sponsors
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
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Capacity | Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy | Assessed by six-minute walk test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Arterial Stiffness | Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy | 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. |
| 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. |
| 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. |
| 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. |
| Body Weight | Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy | 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. |
| Muscle Mass | Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy | 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. |
| C-Reactive Protein | Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy | — |
| Albumin | Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy | — |
| Hemogram | Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy | — |
| 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. |
Countries
Portugal
Contacts
PRINCIPAL_INVESTIGATORCatarina Garcia, Msc
Research Center of Sports Science Health Science and Human Development - University of Maia
Outcome results
None listed