Exercise Prehabilitation in Patients With Head and Neck Squamous-cell Carcinoma: The FIT4TREAT Trial
- Conditions
- Head and Neck Neoplasms
- Interventions
- Other: Prehabilitation
- Registration Number
- NCT05418842
- Lead Sponsor
- Associacao de Investigacao de Cuidados de Suporte em Oncologia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 46
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prehabilitation Group Prehabilitation 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).
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.
Overall Survival From baseline to 5 years after diagnosis Defined as the time from randomization to death from any cause.
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 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 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 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.
Body Weight 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 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session Assessed by bioelectrical impedance.
C-Reactive Protein Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session Albumin Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session Hemogram Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session 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.
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.
Muscle Mass 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 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.
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.
Trial Locations
- Locations (5)
University of Maia
🇵🇹Maia, Porto, Portugal
Liga Portuguesa Contra o Cancro - Núcleo Regional do Norte (LPCC-NRN)
🇵🇹Porto, Portugal
Instituto Português de Oncologia do Porto (IPO-Porto)
🇵🇹Porto, Região, Portugal
University of Aveiro
🇵🇹Aveiro, Portugal
Centro Hospitalar Vila Nova de Gaia/Espinho
🇵🇹Vila Nova De Gaia, Porto, Portugal