Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2025-12-17 @ 6:25 PM
Study NCT ID:
NCT06412510
Status:
None
Last Update Posted:
2025-11-26 00:00:00
First Post:
2024-05-08 00:00:00
Brief Title:
Prehabilitation for EOC, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer w/ NACT
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Prehabilitation for Elderly Patients With Advanced Epithelial Ovarian, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer Undergoing Neoadjuvant Chemotherapy
Status:
None
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Elderly participants with epithelial ovarian cancer (EOC) and pancreatic adenocarcinoma (PDAC) undergoing neoadjuvant chemotherapy (NACT) are often frail and malnourished. Both chemotherapy and disease burden are associated with a decline in muscle mass leading to decrease in physical strength and cardiovascular fitness. Limited efforts have focused on decreasing morbidity at time of chemotherapy and surgery and improving functional capacity. Exercise during chemotherapy has been shown to improve chemotherapy related symptoms and quality of life in participants with breast cancer participants. In surgical patient populations, preoperative rehabilitation (prehabilitation) has been shown to improve walking capacity, decrease hospital length of stay, perioperative complications, and cost. However, whether multimodal prehabilitation improves the functional capacity and perioperative outcomes of EOC and PDAC participants undergoing NACT compared to standard of care is unknown. Investigators aim to evaluate if prehabilitation in participants with EOC and PDAC undergoing NACT improves physical fitness/ functional outcomes, perioperative outcomes, nutritional status, and quality of life compared to standard of care.
Detailed Description:
Elderly participants with epithelial ovarian cancer EOC and pancreatic adenocarcinoma PDAC undergoing neoadjuvant chemotherapy NACT are often frail and malnourished Both chemotherapy and disease burden are associated with a decline in muscle mass leading to decrease in physical strength and cardiovascular fitness Limited efforts have focused on decreasing morbidity at time of chemotherapy and surgery and improving functional capacity Exercise during chemotherapy has been shown to improve chemotherapy related symptoms and quality of life in participants with breast cancer participants In surgical patient populations preoperative rehabilitation prehabilitation has been shown to improve walking capacity decrease hospital length of stay perioperative complications and cost However whether multimodal prehabilitation improves the functional capacity and perioperative outcomes of EOC and PDAC participants undergoing NACT compared to standard of care is unknown Investigators aim to evaluate if prehabilitation in participants with EOC and PDAC undergoing NACT improves physical fitness functional outcomes perioperative outcomes nutritional status and quality of life compared to standard of care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None