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

Associacao de Investigacao de Cuidados de Suporte em Oncologia47 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Head and Neck Neoplasms

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

University of Maia

Maia, Porto District, Portugal

Centro Hospitalar Vila Nova de Gaia/Espinho

Vila Nova de Gaia, Porto District, Portugal

Instituto Português de Oncologia do Porto (IPO-Porto)

Porto, Região, Portugal

University of Aveiro

Aveiro, Portugal

Liga Portuguesa Contra o Cancro - Núcleo Regional do Norte (LPCC-NRN)

Porto, Portugal

Outcomes

Primary Outcomes

Functional Capacity

Assessed by six-minute walk test.

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

Secondary Outcomes

Functional Capacity

Assessed by six-minute walk test.

Time frame: 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.

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

Isometric Handgrip Muscle Strength

Assessed by hand dynamometer.

Time frame: 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.

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

Arterial Stiffness

Assessed by carotid-femoral pulse wave velocity.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

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.

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

Assessed by bioelectrical impedance.

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

Body Weight

Assessed by bioelectrical impedance.

Time frame: 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.

Time frame: 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.

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

Muscle Mass

Assessed by bioelectrical impedance.

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

Muscle Mass

Assessed by bioelectrical impedance.

Time frame: 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.

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

Percentage of Body Fat

Assessed by bioelectrical impedance.

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

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

Time frame: 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.

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

Treatment-Related Adverse Events

Assessed by CTCAE-vs.5.

Time frame: 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.

Time frame: From baseline to 5 years after diagnosis

Overall Survival

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

Time frame: From baseline to 5 years after diagnosis