NCT06593639Recruiting
Effect of Prehabilitation on Head and Neck Cancer Patients
Does Prehabilitation be Able to Favorably Impact on the Pathway of Head and Neck Cancer Patients, Candidate to Surgery or Chemoradiotherapy as Primary Treatment? A Prospective Clinical Trial
Source: ClinicalTrials.gov · Last updated 5 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 6 Sept 2024
- Start date
- 9 Sept 2024
- Primary completion date
- Aug 2026
- Lead sponsor
- Laura Deborah Locati
- Diseases
- Head and neck cancer
- NCT number
- NCT06593639
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 9 Sept 2024 to the primary completion date, Aug 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Frailty subjects: patients with severe functional impairment
Other
- Need for early treatment initiation
- Significant muscle wasting, limiting the participation in prehabilitation exercise
- Severe cognitive or mental health issues, precluding prehabilitation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| National Center of Adrotherapy Oncology Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Istituti Clinici Scientifici Maugeri Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria di Sassari Coordinator of this site? Confirm its status | Sassari | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.