Prehabilitation program for patients with head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the feasibility of a prehabilitation program designed for patients with head and neck cancer, incorporating physical activity, nutritional support, and psychological counseling. The program begins approximately four weeks before surgery or the start of curative chemoradiotherapy and continues throughout treatment and for two weeks post-treatment. The aim is to enhance physical, emotional, and cognitive health, thereby reducing treatment-related complications and improving overall patient outcomes. The study will assess various health metrics at multiple time points to evaluate the program's effectiveness.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• Istituto Nazionale Tumori IRCCS, Fondazione G. Pascale
  Naples, Italy, Italy Recruiting
• Fondazione IRCCS Policlinico San Matteo
  Pavia, Italy, Italy Recruiting
• Istituti Clinici Scientifici Maugeri
  Pavia, Italy, Italy Recruiting
• National Center of Adrotherapy Oncology
  Pavia, Italy, Italy Recruiting
• Azienda Ospedaliero Universitaria di Sassari
  Sassari, Italy, Italy Recruiting

Study contacts

• Study coordinator: Laura D Locati, MD, PhD
• Email: oncologiapavia@icsmaugeri.it
• Phone: +39 0382593585

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.