Prehabilitation program for patients with head and neck cancer
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
This study is testing a prehabilitation program that helps people with head and neck cancer get stronger and healthier before and during their treatment to see if it can improve their overall well-being and reduce complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Locations | 5 sites (Naples, Italy and 4 other locations) |
| Trial ID | NCT06593639 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are fit for curative treatment and able to participate in a prehabilitation program.
Not a fit: Patients with unstable medical conditions, advanced disease stages requiring palliative care, or significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life and treatment outcomes for patients with head and neck cancer.
How similar studies have performed: While there is limited data on multimodal prehabilitation specifically for head and neck cancers, similar approaches in other cancer types have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Naples, Italy and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.