Exercise program to help patients with head and neck cancer before treatment
Exercise Prehabilitation in Patients With Head and Neck Squamous-cell Carcinoma: The FIT4TREAT Trial
This study is testing whether an exercise program can help patients with head and neck cancer feel stronger and better cope with treatment before they start chemotherapy and radiation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Associacao de Investigacao de Cuidados de Suporte em Oncologia Academic / other |
| Locations | 5 sites (Maia, Porto and 4 other locations) |
| Trial ID | NCT05418842 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the impact of an exercise prehabilitation program on the functional capacity of patients with head and neck squamous-cell carcinoma undergoing chemoradiotherapy. Forty-six participants will be randomly assigned to either the prehabilitation group or a usual care group, with the intervention lasting at least two weeks. The primary outcome will be measured using the six-minute walk test, while additional assessments will include muscle strength, quality of life, and treatment tolerance. Data will be collected at diagnosis, before treatment, and four weeks after chemoradiotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed head and neck squamous-cell carcinoma scheduled for chemoradiotherapy.
Not a fit: Patients with uncontrolled hypertension, significant cardiac or pulmonary disease, or contraindications to exercise training may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the physical fitness and overall well-being of patients undergoing treatment for head and neck cancer.
How similar studies have performed: Other studies have shown positive outcomes with exercise prehabilitation in cancer patients, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Maia, Porto and 4 other locations
- University of Maia — Maia, Porto, Portugal (Recruiting)
- Centro Hospitalar Vila Nova de Gaia/Espinho — Vila Nova De Gaia, Porto, Portugal (Recruiting)
- Instituto Português de Oncologia do Porto (IPO-Porto) — Porto, Região, Portugal (Recruiting)
- University of Aveiro — Aveiro, Portugal (Recruiting)
- Liga Portuguesa Contra o Cancro - Núcleo Regional do Norte (LPCC-NRN) — Porto, Portugal (Recruiting)
Study contacts
- Principal investigator: Catarina Garcia, Msc — Research Center of Sports Science Health Science and Human Development - University of Maia
- Study coordinator: Catarina Garcia, Msc
- Email: catarina.garcia@ismai.pt
- Phone: +351229866000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.