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RECRUITING
NCT06593639
NA

Effect of Prehabilitation on Head and Neck Cancer Patients

Sponsor: Laura Deborah Locati

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-09-09

Completion Date

2026-08

Last Updated

2025-12-05

Healthy Volunteers

No

Interventions

OTHER

Prehabilitation before surgery

Prehabilitation multimodal program will start about 4 weeks before the surgery and will be continued until 2 weeks after the surgical intervention. Multimodal program comprises physical exercise, nutritional intervention, and psychological support provided before and during curative treatment for HNC patients.

OTHER

Prehabilitation before and during CRT

Prehabilitation multimodal program will start about 4 weeks CRT and will be continued in parallel until 2 weeks after the end. Multimodal program comprises physical exercise, nutritional intervention, and psychological support provided before and during curative treatment for HNC patients.

Locations (5)

Istituto Nazionale Tumori IRCCS, Fondazione G. Pascale

Naples, Italy, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy, Italy

Istituti Clinici Scientifici Maugeri

Pavia, Italy, Italy

National Center of Adrotherapy Oncology

Pavia, Italy, Italy

Azienda Ospedaliero Universitaria di Sassari

Sassari, Italy, Italy