Pancreatic Cancer Clinical Trial
— PIPSOfficial title:
Multimodal Prehabilitation in Localized Pancreatic Cancer Patients Undergoing Surgery: a Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 226 |
Est. completion date | July 13, 2026 |
Est. primary completion date | July 13, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years - Indication for curative resection for pancreatic or periampullary cancer - Signed Informed consent Exclusion Criteria: - Metastatic or unresectable disease found preoperatively - Comorbidities contraindicating prehabilitation regimen (exercise and nutritional intervention) such as orthopedic, cognitive disabilities, chronic renal failure (dialysis or creatinine >250 mmol) - ASA score 4-5 - Pregnancy - Illiteracy (inability to read and understand Italian language) |
Country | Name | City | State |
---|---|---|---|
Italy | San Raffaele Hospital | Milan | Lombardia |
Lead Sponsor | Collaborator |
---|---|
IRCCS San Raffaele | Ministry of Health, Italy |
Italy,
Lambert JE, Hayes LD, Keegan TJ, Subar DA, Gaffney CJ. The Impact of Prehabilitation on Patient Outcomes in Hepatobiliary, Colorectal, and Upper Gastrointestinal Cancer Surgery: A PRISMA-Accordant Meta-analysis. Ann Surg. 2021 Jul 1;274(1):70-77. doi: 10.1097/SLA.0000000000004527. — View Citation
Mizrahi JD, Surana R, Valle JW, Shroff RT. Pancreatic cancer. Lancet. 2020 Jun 27;395(10242):2008-2020. doi: 10.1016/S0140-6736(20)30974-0. — View Citation
Pecorelli N, Guarneri G, Vallorani A, Limongi C, Licinio AW, Di Salvo F, Tamburrino D, Partelli S, Crippa S, Falconi M. Validation of the PROMIS-29 Questionnaire as a Measure of Recovery after Pancreatic Surgery. Ann Surg. 2023 Jul 19. doi: 10.1097/SLA.0000000000006020. Online ahead of print. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comprehensive Complication Index (CCI) | Postoperative complications occurring during the index admission or in a subsequent readmission, when related to surgery, will be recorded up to 90 days after surgery and graded by severity using the Dindo-Clavien classification and the Comprehensive Complication index (CCI).
The Dindo-Clavien system grades complications according to the therapy needed for treatment: Grade I, are complications that require bedside management; Grade II, are complications that require pharmacologic treatment; Grade III, are complications that require surgical or radiologic intervention and; Grade IV, are complications that require intensive care treatment. Dindo-Clavien Grade III or above are considered severe postoperative complications. The CCI, derived from the Dindo-Clavien system, is a validated metric summarizing the complete spectrum of complications that occurred and their severity in a single score ranging from 0 to 100. |
90 days after surgery | |
Primary | Functional capacity | Functional capacity will be measured by the 6-minute walking test and compared between groups on the day before surgery, at 30-60-90 days after surgery. | One day before surgery; 30 days after surgery; 60 days after surgery; 90 days after surgery | |
Primary | Pro-inflammatory cytokines | Circulating levels of tumor necrosis factor alpha (TNF-a), interleukin 1 (IL-1), interleukin 6 (IL-6), interferon gamma (IFN-?), and macrophage inflammatory protein a (MIP-1a) will be assessed by luminex immunoassays and compared between groups at baseline and one day before surgery. | One day before surgery | |
Primary | Cancer cachexia related factors | Enzyme-linked immunosorbent assay (ELISA) will be used to measure the serum levels of the following cachexia-related factors: Activin A, carnosine dipeptidase-1 and zinc-a2-glycoprotein. The circulating levels will be compared between groups at baseline and one day before surgery. | One day before surgery | |
Secondary | Time to patient functional recovery (TFR) | TFR will be measured by subtracting the date of surgery from the date when participants achieve standardized criteria (tolerance of oral intake, recovery of lower gastrointestinal function, adequate pain control on oral analgesia, ability to mobilize and self-care and no evidence of untreated medical problems) | 90 days after surgery | |
Secondary | Lenght of stay (LOS) | LOS will be measured by subtracting the date of surgery from the date of discharge | 90 days after surgery | |
Secondary | Bioimpedance analysis (BIA) derived body composition | Extracellular and intracellular water as % of total body water, fat mass (FM) as % of body weight, skeletal muscle mass (SK) as % of fat-free mass (FFM), phase angle (PA°) and intramuscular fat mass (IMAT) will be assessed using bioimpedance analysis and compared between groups at baseline, on the day before surgery, at 30, 60, 90 days after surgery. | One day before surgery; 30 days after surgery; 60 days after surgery; 90 days after surgery | |
Secondary | Computed tomography derived body composition | Skeletal muscle area (cm2), visceral fat area (cm2) and intra-muscular fat infiltration will be measured at the level of the third lumbar vertebra using preoperative CT scan imaging and compared between groups at baseline and on the day before surgery. | One day before surgery. | |
Secondary | Generic health-related quality of life | Generic health-related quality of life will be measured using the Patient Reported Outcome Measure Information System (PROMIS)-29+2 Profile v2.1 (PROPr), a questionnaire designed to measure self-reported physical, mental and social health and wellbeing. Questions are ranked on a 5-point Likert Scale. Each domain (Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities) is scored from 4 to 20. For negative domains (i.e. Depression), lower scores represent better outcomes, higher scores represent worse outcomes. For positive domains (i.e. Physical function), lower scores represent worse outcomes, higher scores represent better outcomes. | One day before surgery; 30 days after surgery; 60 days after surgery; 90 days after surgery | |
Secondary | Disease-specific health-related quality of life | Disease-specific health-related quality of life will be measured using the EORTC QLQ C30 and PAN-26 questionnaires, which have been validated to assess quality of life in cancer patients.
EORTC QLQ C30 is a generic core questionnaire that measures health-related quality of life in patients with any cancer. It comprises a total of 30 items on 15 quality of life scales. EORTC QLQ PAN-26, is the pancreatic cancer module that supplements the EORTC QLQ-C30. The module comprises 26 questions that share the 4-level ordinal response options with QLQ-C30. |
One day before surgery; 30 days after surgery; 60 days after surgery; 90 days after surgery |
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