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Effect of Prehabilitation on Head and Neck Cancer Patients
Sponsor: Laura Deborah Locati
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
Conditions
Interventions
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.
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