Effect of Prehabilitation on Head and Neck Cancer Patients
Recruiting now · Not applicable
Conditions studied: Head and Neck Cancer
In brief
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.
Key facts
- Study ID
- NCT06593639
- Run by
- Laura Deborah Locati
- People needed
- 60
- Starts
- 2024-09-09
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2025-12-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Istituto Nazionale Tumori IRCCS, Fondazione G. Pascale — Naples, Italy, Italy (enrolling)
- Fondazione IRCCS Policlinico San Matteo — Pavia, Italy, Italy (enrolling)
- Istituti Clinici Scientifici Maugeri — Pavia, Italy, Italy (enrolling)
- National Center of Adrotherapy Oncology — Pavia, Italy, Italy (enrolling)
- Azienda Ospedaliero Universitaria di Sassari — Sassari, Italy, Italy (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.