MedTrace Logo

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

NCT05418842 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2026-03-25

No results posted yet for this study

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.

Conditions

  • Head and Neck Neoplasms

Interventions

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 16-24 minutes and it will be performed with 8-12 intervals of high intensity (1 minute) and 8-12 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.

Sponsors & Collaborators

  • Research Center in Sports Sciences, Health Sciences and Human Development

    collaborator OTHER

  • University Institute of Maia

    collaborator OTHER

  • Aveiro University

    collaborator OTHER

  • Centro Hospitalar de Vila Nova de Gaia/Espinho

    collaborator OTHER

  • Associacao de Investigacao de Cuidados de Suporte em Oncologia

    lead OTHER

Principal Investigators

  • Catarina Garcia, Msc · Research Center of Sports Science Health Science and Human Development - University of Maia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-28
Primary Completion
2025-03-27
Completion
2025-06-13

Countries

  • Portugal

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05418842 on ClinicalTrials.gov