Clinical trial Recruiting at 3 sites Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment600 (estimated)
SponsorUniversità Vita-Salute San Raffaele
Academic / other
Locations4 sites (Catania and 3 other locations)
StatusRecruiting
StartedDecember 20, 2024
Main results expectedAugust 2026
Study endsNovember 2026
Registry record updatedAugust 6, 2025
Trial IDNCT06744413 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

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.