Status:
RECRUITING
Effect of Prehabilitation on Head and Neck Cancer Patients
Lead Sponsor:
Laura Deborah Locati
Collaborating Sponsors:
Fondazione IRCCS Policlinico San Matteo di Pavia
Azienda Ospedaliero Universitaria di Sassari
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary aim of the study is to investigate the feasibility of a prehabilitation program, which consists of a set of strategies including physical activity, nutritional support, and psychological c...
Detailed Description
Oncological prehabilitation is defined as the process within the care pathway that takes place between the moment of cancer diagnosis and the initiation of acute treatments. Prehabilitation aims to im...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Candidate to curative treatment (platinum-based chemoradiotherapy or surgery + RT +/- CT)
- ECOG PS 0-1
- Fit for prehabilitation program (medical, physical, and mental conditions that don't contraindicate physical exercise and oral nutrition)
- Ability to understand and adhere to exercise or lifestyle modifications
- Date of treatment beginning no later than 60 days from baseline assessment
- Provide valid informed consent prior to any study procedure
Exclusion
- Unstable medical condition requiring immediate attention (e.g uncontrolled heart failure; unstable angina; severe respiratory distress) must prioritize
- Patients with very advanced stage of disease, candidate to palliative treatment
- Uncontrolled cancer symptoms or pain
- Need for early treatment initiation
- Frailty subjects: patients with severe functional impairment
- Significant muscle wasting, limiting the participation in prehabilitation exercise
- Severe cognitive or mental health issues, precluding prehabilitation
Key Trial Info
Start Date :
September 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06593639
Start Date
September 9 2024
End Date
August 1 2026
Last Update
December 5 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Istituto Nazionale Tumori IRCCS, Fondazione G. Pascale
Napoli, Italy, Italy, 80131
2
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, Italy, 27100
3
Istituti Clinici Scientifici Maugeri
Pavia, Italy, Italy, 27100
4
National Center of Adrotherapy Oncology
Pavia, Italy, Italy, 27100