HNCANCERFITNCT06593639

Effect of Prehabilitation on Head and Neck Cancer Patients

StatusRecruiting

PhaseNot applicable

SponsorIstituti Clinici Scientifici Maugeri SpA

Primary completionFeb 2027 (estimated)

At risk: Primary completion moved at least 5 months later.

See at-risk trials from Istituti Clinici Scientifici Maugeri SpA

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Record History

All 4 versions: 3 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

Notable Nov 10, 2026 Lead sponsor: Laura Deborah Locati to Istituti Clinici Scientifici Maugeri SpA Show 4 more changesShow less
- Eligibility criteria expanded, about 14 words
- Primary and study completion pushed from Aug 2026 to Feb 2027
- Site details revised at 5 of 5 sites
- Publications: details revised at 17 of 17 entries
Minor Nov 27, 2025 Site contacts updated at 1 of 5 sitesv3
Sep 9, 2024 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Feasibility of multimodal prehabilitation

Timeframe: From enrollment to the end of prehabilitation program, 2 weeks after the end of curative treatment

Efficacy of multimodal prehabilitation

Timeframe: From enrollment to 2 weeks after the end of oncological treatment

Cost-effectiveness of multimodal prehabilitation

Timeframe: From the enrollment to 6 months after the end of the oncological treatment

Arms and interventions

Surgery plus (chemo)radiotherapyExperimental

Head and neck cancer patients undergoing surgery before (chemo)radiotherapy according to stage and risk factors.

Chemo-radiotherapyExperimental

Head and neck cancer patients undergoing definitive concomitant chemo-radiotherapy (CRT) according to stage and risk factors.

Other: Prehabilitation before surgery, Prehabilitation before and during CRT

Sites

5 sites in 1 country

About this trial

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.

Trial details

Enrollment: 60 participants (estimated)
Started: Sep 9, 2024
Study completion: Feb 2027 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, non-randomized, open label, treatment
Oversight: No data monitoring committee
Conditions: Head and Neck Neoplasms, Malnutrition, Motor Activity, Head and Neck Cancer
Collaborators: Fondazione IRCCS Policlinico San Matteo di Pavia, Azienda Ospedaliero Universitaria di Sassari, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, CNAO National Center of Oncological Hadrontherapy
Official title: 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
First posted: Sep 19, 2024
Registry updated: Nov 13, 2026
Last verified: Nov 2026

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