Status:
RECRUITING
Exercise Prehabilitation in Patients With Head and Neck Squamous-cell Carcinoma: The FIT4TREAT Trial
Lead Sponsor:
Associacao de Investigacao de Cuidados de Suporte em Oncologia
Collaborating Sponsors:
Research Center in Sports Sciences, Health Sciences and Human Development
University Institute of Maia
Conditions:
Head and Neck Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT05418842
Start Date
June 1 2021
End Date
July 31 2025
Last Update
August 5 2024
Active Locations (5)
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1
University of Maia
Maia, Porto District, Portugal, 4475-690
2
Centro Hospitalar Vila Nova de Gaia/Espinho
Vila Nova de Gaia, Porto District, Portugal, 4434-502
3
Instituto Português de Oncologia do Porto (IPO-Porto)
Porto, Região, Portugal
4
University of Aveiro
Aveiro, Portugal, 3810-193