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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Istituto Nazionale Tumori IRCCS, Fondazione G. Pascale
RECRUITING
Napoli
Fondazione IRCCS Policlinico San Matteo
RECRUITING
Pavia
Istituti Clinici Scientifici Maugeri
RECRUITING
Pavia
National Center of Adrotherapy Oncology
RECRUITING
Pavia
Azienda Ospedaliero Universitaria di Sassari
RECRUITING
Sassari
Contact Information
Primary
Laura D Locati, MD, PhD
oncologiapavia@icsmaugeri.it
+39 0382593585
Time Frame
Start Date: 2024-09-09
Estimated Completion Date: 2026-08
Participants
Target number of participants: 60
Treatments
Experimental: Surgery plus (chemo)radiotherapy
Head and neck cancer patients undergoing surgery before (chemo)radiotherapy according to stage and risk factors.
Experimental: Chemo-radiotherapy
Head and neck cancer patients undergoing definitive concomitant chemo-radiotherapy (CRT) according to stage and risk factors.
Related Therapeutic Areas
Sponsors
Collaborators: CNAO National Center of Oncological Hadrontherapy, Fondazione IRCCS Policlinico San Matteo di Pavia, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Azienda Ospedaliero Universitaria di Sassari
Leads: Laura Deborah Locati

This content was sourced from clinicaltrials.gov