Personalized prehabilitation program for cancer surgery patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a personalized, multidisciplinary pre-operative prehabilitation program designed to reduce complications and enhance recovery in high-risk cancer surgery patients. The program includes exercise training, nutritional therapy, and anxiety reduction techniques, aiming to improve patients' functional capacity before undergoing major abdominal, thoracic, or gynecological surgeries. A total of 400 patients will be randomly assigned to either the prehabilitation intervention group or a control group receiving standard care. The study seeks to address the physiological stress and functional decline associated with cancer surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patient (age \> 18 years);
* Scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery;
* Signed informed consent.

Exclusion Criteria:

A) Co-morbid medical, physical, and mental conditions interfering with the ability to complete study procedures, such as:

* Acute or unstable cardio-respiratory conditions (e.g., unstable angina or symptomatic severe aortic stenosis);
* Severe/end-stage organ diseases (e.g., cardiac failure NYHA functional classes III-IV, COPD FEV1 \<50% pred, end-stage kidney or liver disease);
* American Society of Anesthesiologists (ASA) physical status classes 4-5;
* Disabling orthopedic and neuromuscular disease;
* Psychosis, dementia;
* Symptomatic anemia with a hemoglobin value \< 7 gr/dl.

B) Patients with both optimal functional capacity (a Duke activity status index \[DASI\] score \> 45) and optimal nutritional status (NRS-nutrition screening tool-score \< 2).

Where it's running

• Policlinico Universitario AOU Renato Dulbecco di Catanzaro
  Catanzaro, Italy, Italy Recruiting
• Ospedale Vanvitelli di Napoli
  Naples, Italy, Italy Recruiting
• IRCCS Ospedale San Raffaele
  Milan, Milan, Italy Recruiting
• AOU Careggi
  Florence, Italy, Italy Not yet recruiting
• Ospedale Galliera di Genova
  Genova, Italy, Italy Not yet recruiting
• ASSTN GOM Niguarda
  Milan, Italy, Italy Not yet recruiting

Study contacts

• Principal investigator: Marina Pieri, Medical Doctor — IRCCS Ospedale San Raffaele
• Study coordinator: Marina LG Pieri, Medical Doctor
• Email: pieri.marina@hsr.it
• Phone: +393334625052

Similar studies

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

• 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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• Prehabilitation program to improve heart rate variability in cancer surgery patients

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  Recruiting Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Pittsburgh, Pennsylvania · NCT06731998

• Managing body temperature during cancer surgery to reduce delirium and improve survival

  This study tests if keeping older patients at a specific body temperature during major cancer surgery can help reduce confusion after surgery and improve their chances of survival.

  Recruiting at 21 sites Peking University First Hospital · Chizhou, Anhui and 35 other locations · NCT06256354

• Using dexmedetomidine to improve long-term survival after cancer surgery in older patients

  This study tests if giving older patients a medication called dexmedetomidine during cancer surgery can help them recover better and live longer.

  Recruiting at 34 sites Peking University First Hospital · Hefei, Anhui and 39 other locations · NCT06030804

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.