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

Not Applicable

Recruiting

• Conditions: Head and Neck Neoplasms

• 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

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2022-05-16
• Study First Submitted QC: 2022-06-13
• Study First Posted: 2022-06-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-05
• Primary Completion: 2024-12-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

Centro Hospitalar Vila Nova de Gaia/Espinho; 🇵🇹 Vila Nova De Gaia, Porto, 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