Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06275737
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2024-02-01
Brief Title:
POP-UP a Single-arm Two-cohort Study Trimodal Prehab for Upper GI and Pancreatic Cancer
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
GERCOR - Multidisciplinary Oncology Cooperative Group
Study Overview
Official Title:
Trimodal Peri Operative Prehabilitation for Upper Oesogastric and Pancreatic Cancer A Multicenter Two-cohort Open-label Single-arm POP-UP GERCOR Study
Status:
RECRUITING
Status Verified Date:
2024-07
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:
POP-UP
Brief Summary:
This is a multicenter two-cohort open-label single-arm feasibility study The primary objective is to assess the feasibility of the 8-week trimodal prehabilitation program alongside perioperative triplet chemotherapy in eligible patients with localized pancreatic ductal adenocarcinoma PDAC or oesogastric cancer OGC
Detailed Description:
The POP-UP study aims to evaluate the feasibility and preliminary efficacy of an 8-week trimodal preposthabilitation program consisting of personalized Adapted Physical Activity APA nutritional assessment and psychological support with remote monitoring of the APA sessions and nurse coordination in patients with localized resectable or borderline resectable PDAC who are treated with neoadjuvant or induction treatment FOLFIRINOX 5-fluorouracilfolinic acid oxaliplatin irinotecan prior to surgery and with resectable OGC treated with perioperative chemotherapy FLOT 5-fluorouracilfolinic acid oxaliplatin docetaxel
The prehabilitation program will be conducted during neoadjuvant chemotherapy and the 3-5 weeks prior to surgery for a total of 8 weeks before surgery There will be a total of three prehabilitation hospital days during the prehabilitation program
The preoperative prehabilitation will include
Once per month a prehabilitation hospital-day with functional capacities assessment with validated tests made by a physiotherapist or an APA professional according of center resourcesfunctioning medical and nurse assessment evaluating performance status chemotherapy toxicity and tolerance and nutritional assessment according to the functioning of each center it will be made by these professionals -with university training on nutrition- or a dietician A therapeutic training session on the adherence to the prehabilitation program will be done by the nurse trained in therapeutic education
Weekly an APA professional trainer will follow via using app Activiti the APA home-based program It will be based on the functional capacities assessment made during the prehabilitation hospital day The exercise training program will consist of twice per week autonomy sessions supervised and adapted by the APA professional and once per week a guided session with the APA professional The patient will have a total of 3 physical activity sessions per week
Once per week the nurse practitioner or case manager according to center functioning will evaluate the patient via a videoconference to assess the chemotherapy toxicity and tolerance and patients weight modifications
The posthabilitation program will start for a total of 8 weeks one week after surgery discharge The structure is the same as the prehabilitation program except for the follow of chemotherapy toxicity and tolerance that will be replaced by the follow of the surgical complicationsconsequences
There will be a total of three posthabilitation days at hospital during the posthabilitation program
The prehabilitation program will be conducted during neoadjuvant chemotherapy and the 3-5 weeks prior to surgery for a total of 8 weeks before surgery There will be a total of three prehabilitation hospital days during the prehabilitation program
The preoperative prehabilitation will include
Once per month a prehabilitation hospital-day with functional capacities assessment with validated tests made by a physiotherapist or an APA professional according of center resourcesfunctioning medical and nurse assessment evaluating performance status chemotherapy toxicity and tolerance and nutritional assessment according to the functioning of each center it will be made by these professionals -with university training on nutrition- or a dietician A therapeutic training session on the adherence to the prehabilitation program will be done by the nurse trained in therapeutic education
Weekly an APA professional trainer will follow via using app Activiti the APA home-based program It will be based on the functional capacities assessment made during the prehabilitation hospital day The exercise training program will consist of twice per week autonomy sessions supervised and adapted by the APA professional and once per week a guided session with the APA professional The patient will have a total of 3 physical activity sessions per week
Once per week the nurse practitioner or case manager according to center functioning will evaluate the patient via a videoconference to assess the chemotherapy toxicity and tolerance and patients weight modifications
The posthabilitation program will start for a total of 8 weeks one week after surgery discharge The structure is the same as the prehabilitation program except for the follow of chemotherapy toxicity and tolerance that will be replaced by the follow of the surgical complicationsconsequences
There will be a total of three posthabilitation days at hospital during the posthabilitation program
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