NCT05418842Completed
Exercise Prehabilitation in Patients With Head and Neck Squamous-cell Carcinoma: The FIT4TREAT Trial
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 47 (actual)
- First submitted
- 16 May 2022
- Start date
- 28 May 2021
- Primary completion date
- 27 Mar 2025
- Lead sponsor
- Associacao de Investigacao de Cuidados de Suporte em Oncologia
- Diseases
- Head and neck cancer
- NCT number
- NCT05418842
What you commit to
- Study type: Interventional
- Participants enrolled: 47
- From 28 May 2021 to the primary completion date, 27 Mar 2025
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Completion of previous anticancer treatment within less than a year;
Other illness
- Uncontrolled hypertension, cardiac or pulmonary disease;
Other
- Contraindications to exercise training;
- Inability to provide informed consent;
- Expected inability to fulfil the proposed schedule.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Aveiro Coordinator of this site? Confirm its status | Aveiro | Portugal | Unknown status |
| University of Maia Coordinator of this site? Confirm its status | Maia | Portugal | Unknown status |
| Instituto Português de Oncologia do Porto (IPO-Porto) Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| Liga Portuguesa Contra o Cancro - Núcleo Regional do Norte (LPCC-NRN) Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| Centro Hospitalar Vila Nova de Gaia/Espinho Coordinator of this site? Confirm its status | Vila Nova de Gaia | Portugal | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.