Actively Recruiting
Effect of Prehabilitation on Head and Neck Cancer Patients
Led by Laura Deborah Locati · Updated on 2025-12-05
60
Participants Needed
5
Research Sites
98 weeks
Total Duration
On this page
Sponsors
L
Laura Deborah Locati
Lead Sponsor
F
Fondazione IRCCS Policlinico San Matteo di Pavia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 counseling, carried out before and during cancer treatment for patients affected by head and neck tumors. About 4 weeks before surgery or the start of curative chemo-radiotherapy, the patient will begin the prehabilitation program, which will continue in parallel throughout the duration of the treatment and for up to 2 weeks after its completion. This prehabilitation program will include a combination of physical activity exercises, nutritional counseling, and psychological counseling sessions, all of which will be individualized for each patient. At the time of tumor diagnosis (T0), after 4 weeks of prehabilitation and before the start of the planned treatment (T1), 2 weeks after the end of treatment (T2), and after 6 months (T3), the patient will undergo a medical visit to collect anthropometric data, vital signs, a 6-minute walk test, and will complete a series of questionnaires aimed at assessing the risk of malnutrition, the development of anxiety and depression, and questionnaires to evaluate their quality of life. Throughout the duration of the study (i.e., up to T3, 6 months after the end of cancer treatment), the patient will wear an electronic watch, provided by the study, designed to measure vital signs, the number of daily steps, and the type and minutes of physical activity.
CONDITIONS
Official Title
Effect of Prehabilitation on Head and Neck Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63 18 years
- Candidate for curative treatment (platinum-based chemoradiotherapy or surgery plus radiotherapy with or without chemotherapy)
- ECOG performance status 0-1
- Medically, physically, and mentally fit to participate in prehabilitation program
- Ability to understand and follow exercise or lifestyle modifications
- Planned treatment start within 60 days from baseline assessment
- Provide valid informed consent before any study procedure
You will not qualify if you...
- Unstable medical conditions requiring immediate attention (e.g., uncontrolled heart failure, unstable angina, severe respiratory distress)
- Very advanced disease stage, receiving palliative treatment
- Uncontrolled cancer symptoms or pain
- Need for early treatment initiation
- Severe functional impairment (frailty)
- Significant muscle wasting that limits participation in exercise
- Severe cognitive or mental health issues preventing prehabilitation participation
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Istituto Nazionale Tumori IRCCS, Fondazione G. Pascale
Naples, Italy, Italy, 80131
Actively Recruiting
2
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, Italy, 27100
Actively Recruiting
3
Istituti Clinici Scientifici Maugeri
Pavia, Italy, Italy, 27100
Actively Recruiting
4
National Center of Adrotherapy Oncology
Pavia, Italy, Italy, 27100
Actively Recruiting
5
Azienda Ospedaliero Universitaria di Sassari
Sassari, Italy, Italy, 07100
Actively Recruiting
Research Team
L
Laura D Locati, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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