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Effect of Prehabilitation on Head and Neck Cancer Patients

RECRUITINGN/ASponsored by Laura Deborah Locati
Actively Recruiting
PhaseN/A
SponsorLaura Deborah Locati
Started2024-09-09
Est. completion2026-08
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerHead and Neck Cancer

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