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Getting fit before cancer treatment: new study tests prehabilitation for head and neck cancer

NCT ID NCT06593639

Knowledge-focused Sponsor: Laura Deborah Locati Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a prehabilitation program—combining physical exercise, nutritional support, and psychological counseling—can help head and neck cancer patients before and during their main treatment (surgery or chemoradiotherapy). About 60 adults will start the program about 4 weeks before treatment and continue until 2 weeks after. Researchers will measure how well patients stick with the program and track changes in fitness, nutrition, and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
prehabilitation program (physical exercise, nutritional support, psychological counseling)
What this could lead to
If it works, this could show that a prehabilitation program helps head and neck cancer patients stay stronger and recover better during and after treatment.
What could go wrong
This is a small, early feasibility study with only 60 participants, so results may not apply to everyone. The program requires significant effort and commitment from patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms Malnutrition Motor Activity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    5 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Azienda Ospedaliero Universitaria di Sassari

    RECRUITING

    Sassari, Italy, 07100, Italy

  • Fondazione IRCCS Policlinico San Matteo

    RECRUITING

    Pavia, Italy, 27100, Italy

  • Istituti Clinici Scientifici Maugeri

    RECRUITING

    Pavia, Italy, 27100, Italy

    Contact Email: •••••@•••••

  • Istituto Nazionale Tumori IRCCS, Fondazione G. Pascale

    RECRUITING

    Naples, Italy, 80131, Italy

  • National Center of Adrotherapy Oncology

    RECRUITING

    Pavia, Italy, 27100, Italy

    Contact Email: •••••@•••••

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