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

Head and Neck Neoplasms Clinical Trial

— FIT4TREAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05418842
• Other study ID #: F4T
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Associacao de Investigacao de Cuidados de Suporte em Oncologia
• Contact: Catarina Garcia, Msc
• Phone: +351229866000
• Email: catarina.garcia[@]ismai.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Squamous Cell Carcinoma of Head and Neck

Intervention

Other:
• Prehabilitation
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 16-20 minutes and it will be performed with 8-10 intervals of high intensity (1 minute) and 8-10 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.

Locations

Country	Name	City	State
Portugal	University of Aveiro	Aveiro
Portugal	University of Maia	Maia	Porto
Portugal	Instituto Português de Oncologia do Porto (IPO-Porto)	Porto	Região
Portugal	Liga Portuguesa Contra o Cancro - Núcleo Regional do Norte (LPCC-NRN)	Porto
Portugal	Centro Hospitalar Vila Nova de Gaia/Espinho	Vila Nova De Gaia	Porto

Sponsors (5)

Lead Sponsor	Collaborator
Associacao de Investigacao de Cuidados de Suporte em Oncologia	Aveiro University, Centro Hospitalar de Vila Nova de Gaia/Espinho, Research Center in Sports Sciences, Health Sciences and Human Development, University Institute of Maia

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Capacity	Assessed by six-minute walk test.	Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Secondary	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
Secondary	Isometric Handgrip Muscle Strength	Assessed by hand dynamometer.	Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Secondary	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
Secondary	Arterial Stiffness	Assessed by carotid-femoral pulse wave velocity.	Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Body Weight	Assessed by bioelectrical impedance.	Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Secondary	Body Weight	Assessed by bioelectrical impedance.	Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Secondary	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
Secondary	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
Secondary	Muscle Mass	Assessed by bioelectrical impedance.	Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Secondary	Muscle Mass	Assessed by bioelectrical impedance.	Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Secondary	Percentage of Body Fat	Assessed by bioelectrical impedance.	Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Secondary	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
Secondary	C-Reactive Protein		Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Secondary	C-Reactive Protein		Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Secondary	Albumin		Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Secondary	Albumin		Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Secondary	Hemogram		Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
Secondary	Hemogram		Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session
Secondary	Unplanned hospital visits		From baseline to 4 Weeks after last radiotherapy session
Secondary	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
Secondary	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
Secondary	Treatment-Related Adverse Events	Assessed by CTCAE-vs.5.	From the beginning of radiotherapy/chemotherapy to 4 Weeks after last radiotherapy session
Secondary	Progression-Free Survival	Defined as the time from randomization to the occurrence of disease progression or death.	From baseline to 5 years after diagnosis
Secondary	Overall Survival	Defined as the time from randomization to death from any cause.	From baseline to 5 years after diagnosis