RecruitingNot ApplicableNCT05418842

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

Sponsor

Associacao de Investigacao de Cuidados de Suporte em Oncologia

Enrollment

46 participants

Start Date

Jun 1, 2021

Study Type

INTERVENTIONAL

Conditions

Head and Neck Neoplasms

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an exercise program completed before cancer treatment (called prehabilitation) can improve outcomes for people with head and neck cancer receiving chemoradiotherapy. Getting physically fitter before treatment may help patients tolerate it better and recover more quickly. **You may be eligible if...** - You are 18 or older - You have been diagnosed with squamous cell carcinoma of the head and neck (mouth, throat, larynx, or related areas), including stage I–IV - You are scheduled to receive chemotherapy and radiation together with the aim of curing the cancer - Your treatment is planned to start within a few weeks, giving time for the exercise program **You may NOT be eligible if...** - You have a condition that prevents safe exercise (e.g., severe heart or lung problems) - You have a physical disability that prevents exercise participation - You have already started cancer treatment - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 16-20 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.