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

Inclusion Criteria5

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 Criteria5

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.

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.