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

NCT05418842 | Completed

• 1 other identifier: F4T
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Prehabilitation; Exercise; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Functional Capacity

  Assessed by six-minute walk test.

  Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy

Secondary Outcomes (33)

• Functional Capacity

  Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session

• Isometric Handgrip Muscle Strength

  Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy

• Isometric Handgrip Muscle Strength

  Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session

• Arterial Stiffness

  Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy

• Arterial Stiffness

  Change from 1-3 days before the beginning of radiotherapy to 4 Weeks after last radiotherapy session

Study Arms (2)

Prehabilitation Group

EXPERIMENTAL

In addition to standard medical care, the prehabilitation group will have three supervised exercise training sessions per week from diagnosis to start of radiotherapy (pre-treatment phase).

Other: Prehabilitation

Control Group

NO INTERVENTION

The control group will receive the standard medical care.

Interventions

Prehabilitation OTHER

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.

Prehabilitation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (5)

University of Maia

Maia, Porto District, 4475-690, Portugal

Location

Centro Hospitalar Vila Nova de Gaia/Espinho

Vila Nova de Gaia, Porto District, 4434-502, Portugal

Location

Instituto Português de Oncologia do Porto (IPO-Porto)

Porto, Região, Portugal

Location

University of Aveiro

Aveiro, 3810-193, Portugal

Location

Liga Portuguesa Contra o Cancro - Núcleo Regional do Norte (LPCC-NRN)

Porto, Portugal

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Motor Activity

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Behavior

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Catarina Garcia, Msc

  Research Center of Sports Science Health Science and Human Development - University of Maia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: June 14, 2022
• Study Start: May 28, 2021
• Primary Completion: March 27, 2025
• Study Completion: June 13, 2025
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

PT (5)