RecruitingNot ApplicableNCT06593639

Effect of Prehabilitation on Head and Neck Cancer Patients

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


Sponsor

Laura Deborah Locati

Enrollment

60 participants

Start Date

Sep 9, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a "prehabilitation" program — exercise and nutrition support before cancer treatment begins — to help head and neck cancer patients arrive at treatment in better physical shape and recover more quickly. **You may be eligible if...** - You are 18 or older - You have head and neck cancer and are planning to receive chemoradiation or surgery followed by radiation - You are otherwise healthy enough to exercise and eat adequately - Your treatment start date is within 60 days of your initial assessment - Your general health status is good (ECOG 0-1) **You may NOT be eligible if...** - You have an unstable heart condition, uncontrolled heart failure, or serious breathing problems - Your cancer is at a very advanced stage and only palliative (comfort-focused) treatment is planned - You have severe pain or uncontrolled cancer symptoms - You have severe physical weakness or significant muscle wasting that prevents exercise - You have serious cognitive or mental health issues Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPrehabilitation 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.

OTHERPrehabilitation 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

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NCT06593639


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