Prehabilitation program to improve heart rate variability in cancer surgery patients
Prehabilitation to Improve Heart Rate Variability In Surgical Cancer Patients: a randoMized controllEd Trial
This study tests if a special program that includes exercise, nutrition, and support can help cancer patients get stronger and recover better before major surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Università Vita-Salute San Raffaele Academic / other |
| Locations | 4 sites (Catania and 3 other locations) |
| Trial ID | NCT06744413 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a multimodal prehabilitation program designed for cancer patients scheduled for major abdominal or thoracic surgery. The program aims to enhance patients' functional capacity and ability to cope with physiological stress before surgery through interventions such as exercise, nutrition, and psychological support. Heart rate variability (HRV) will be used as an objective measure to assess the impact of prehabilitation on patients' recovery and surgical outcomes. The study is a multicenter, randomized trial involving chronic cancer patients across multiple international locations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for elective major abdominal or thoracic cancer surgery and can engage with a smartphone application.
Not a fit: Patients with very poor functional capacity or those classified as ASA physical status classes 5-6 may not benefit from this prehabilitation program.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and recovery for cancer patients undergoing major surgeries.
How similar studies have performed: While prehabilitation is gaining attention, the specific use of heart rate variability as an objective measure in this context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Scheduled to undergo elective major abdominal or thoracic cancer surgery; 2. Scheduled to undergo surgery at least three weeks after enrollment; 3. Age ≥ 18 years; 4. Provide written informed consent; 5. Willing and able to use smartphone application. Exclusion Criteria: 1. Presenting with very poor functional capacity; 2. American Society of Anesthesiologists (ASA) physical status classes 5-6; 3. Disabling orthopedic, neuromuscular, and psychiatric diseases or other conditions that preclude participation in a prehabilitation program.
Where this trial is running
Catania and 3 other locations
- Azienda Ospedaliero Universitaria Policlinico San Marco di Catania — Catania, Italy (Active_not_recruiting)
- Università di Foggia — Foggia, Italy (Recruiting)
- IRCCS Ospedale San Raffaele — Milan, Italy (Recruiting)
- Azienda Ospedaliero Universitaria Pisana — Pisa, Italy (Recruiting)
Study contacts
- Principal investigator: Fabio Guarracino, Doctor — Azienda Ospedaliero, Universitaria Pisana
- Study coordinator: Fabio Guarracino, Dr
- Email: f.guarracino@ao-pisa.toscana.it
- Phone: +393281652528
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.