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

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

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.

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.