Multimodal Prehabilitation in Localized Pancreatic Cancer Patients Undergoing Surgery: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

In patients with pancreatic cancer, older age, multiple comorbidities, frailty, malnutrition and poor functional status are common, especially in individuals receiving neoadjuvant chemotherapy. These characteristics represent potentially modifiable risk factors for poor postoperative outcomes. The goal of this clinical randomized controlled trial is to evaluate the extent to which a four-week multimodal prehabilitation program impacts on postoperative morbidity, functional and nutritional status and health-related quality of life in patients with localized pancreatic or periampullary cancer scheduled for curative surgery. In addition, the impact of prehabilitation on circulating sarcopenia and cancer cachexia biomarkers in PDAC patients will be explored. Included patients will be randomized (ratio 1:1) and allocated either to the intervention group (Multimodal Prehabilitation), which will receive prehabilitation, or to the control group, which will receive no prehabilitation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Indication for curative resection for pancreatic or periampullary cancer

• Signed Informed consent

Locations
Other Locations
Italy
San Raffaele Hospital
RECRUITING
Milan
Contact Information
Primary
Nicolò Pecorelli, MD
pecorelli.nicolo@hsr.it
+390226432111
Backup
Francesca Di Salvo, PhD
disalvo.francesca@hsr.it
+390226436046
Time Frame
Start Date: 2023-07-14
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 238
Treatments
Experimental: Multimodal Prehabilitation
The intervention consists of a supervised multimodal prehabilitation program (exercise, nutritional support, and psychosocial counseling) conducted for a minimum of four weeks prior to surgery, during the waiting time following patient enrolment.
No_intervention: Usual care
Usual preoperative care. Patients in the control group will be treated according to usual care and will be given informative material regarding a healthy lifestyle and how to best prepare for surgery.
Sponsors
Collaborators: Ministero della Salute, Italy
Leads: IRCCS San Raffaele

This content was sourced from clinicaltrials.gov