NCT06788834 Multimodal Prehabilitation in Cancer Surgery
| NCT ID | NCT06788834 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Università Vita-Salute San Raffaele |
| Condition | Cancer Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-01-30 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2025-01-30 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The PROPOSE RCT is a two-arm randomized controlled trial that will be conducted to test the efficacy of a personalized, multidisciplinary pre-operative prehabilitation program (preventive prehabilitation) to reduce serious complications and facilitate recovery after surgery in high-risk patients. The multimodal prehabilitation program is a preoperative intervention that includes exercise training, nutritional therapy and anxiety reduction techniques, with the aim of preventing or mitigating the functional decline brought about by surgery. 400 patients scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery will be enrolled. They will be randomized (1:1 ratio) and assigned either to the intervention group (Prehabilitation) or to the control group, which will only be treated according to the usual standard of care within the Enhanced Recovery After Surgery (ERAS) pathways.
Eligibility Criteria
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).
Contact & Investigator
Marina Pieri, Medical Doctor
PRINCIPAL INVESTIGATOR
IRCCS Ospedale San Raffaele
Frequently Asked Questions
Who can join the NCT06788834 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06788834 currently recruiting?
Yes, NCT06788834 is actively recruiting participants. Contact the research team at pieri.marina@hsr.it for enrollment information.
Where is the NCT06788834 trial being conducted?
This trial is being conducted at Catanzaro, Italy, Florence, Italy, Genova, Italy, Milan, Italy and 5 additional locations.
Who is sponsoring the NCT06788834 clinical trial?
NCT06788834 is sponsored by Università Vita-Salute San Raffaele. The principal investigator is Marina Pieri, Medical Doctor at IRCCS Ospedale San Raffaele. The trial plans to enroll 400 participants.
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.