NCT06593639 Effect of Prehabilitation on Head and Neck Cancer Patients
| NCT ID | NCT06593639 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Laura Deborah Locati |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-09-09 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-09-09 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06593639 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06593639 currently recruiting?
Yes, NCT06593639 is actively recruiting participants. Contact the research team at oncologiapavia@icsmaugeri.it for enrollment information.
Where is the NCT06593639 trial being conducted?
This trial is being conducted at Naples, Italy, Pavia, Italy, Pavia, Italy, Pavia, Italy and 1 additional location.
Who is sponsoring the NCT06593639 clinical trial?
NCT06593639 is sponsored by Laura Deborah Locati. The trial plans to enroll 60 participants.
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