Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06593639

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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