Clinical trial · Interventional
Exercise Prehabilitation in Patients With Head and Neck Squamous-cell Carcinoma: The FIT4TREAT Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prehabilitation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prehabilitation Group
- description
- 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).
- interventionNames
- Other: Prehabilitation
- type
- NO_INTERVENTION
- label
- Control Group
- description
- The control group will receive the standard medical care.
Primary outcomes (1)
- measure
- Functional Capacity
- timeFrame
- Change from Baseline (at diagnosis) to 1-3 days before the beginning of radiotherapy
- description
- Assessed by six-minute walk test.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDGarcia C, Leao I, Pinto D, Rato ND, Campolargo A, Dias I, Monteiro AR, Soares AM, Basto R, Dias E, Vilela E, Teixeira M, Coimbra E, Oliveira P, Amarelo A, Capela A, Viamonte S, Costa H, Joaquim A, Ribeiro F, Alves AJ. Exercise prehabilitation in head and neck cancer patients proposed for definitive chemoradiotherapy: The FIT4TREAT randomized controlled trial. Oral Oncol. 2026 Aug 31;181:108119. doi: 10.1016/j.oraloncology.2026.108119. Online ahead of print. PMID 42673774