Prehabilitation program to improve heart rate variability in cancer surgery patients
Official title: Prehabilitation to Improve Heart Rate Variability In Surgical Cancer Patients: a randoMized controllEd Trial
Run by Università Vita-Salute San Raffaele · NCT06744413 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Università Vita-Salute San Raffaele Academic / other |
| Locations | 4 sites (Catania and 3 other locations) |
| Status | Recruiting |
| Started | December 20, 2024 |
| Main results expected | August 2026 |
| Study ends | November 2026 |
| Registry record updated | August 6, 2025 |
| Trial ID | NCT06744413 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Università di Foggia
Foggia, Italy Recruiting -
IRCCS Ospedale San Raffaele
Milan, Italy Recruiting -
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy Recruiting -
Azienda Ospedaliero Universitaria Policlinico San Marco di Catania
Catania, Italy Active not 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Virtual group prehabilitation education (GoPREPARE) for people awaiting cancer surgery
This trial will test whether a virtual group prehabilitation class called GoPREPARE helps adults waiting for elective cancer surgery improve their fitness, nutrition, and readiness for surgery.
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This study tests a personalized program that combines exercise, nutrition, and anxiety relief to see if it helps high-risk cancer surgery patients recover better and avoid complications.
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Using dexmedetomidine to improve long-term survival after cancer surgery in older patients
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.