POP-UP: a Single-arm, Two-cohort Study: an 8-week Trimodal Pre-habilitation Program for Patients With Pancreatic Ductal Adenocarcinoma and Oesogastric (POP-UP)

Trimodal Peri Operative Prehabilitation for Upper Oesogastric and Pancreatic Cancer: A Multicenter, Two-cohort, Open-label, Single-arm POP-UP GERCOR Study

This is a prospective, multicenter, two-cohort, open-label, single-arm feasibility study of a trimodal (nutritional, psychological, and personalized Adapted Physical Activity (APA)-individualized interventions) 8-week prehabilitation program in patients with localized pancreatic ductal adenocarcinoma (PDAC) or oesogastric cancer (OGC) receiving peri-operative triple chemotherapy and undergoing surgery.

Study Overview

• Status: Active, not recruiting
• Conditions: Esophageal Cancer; Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Other: Prehabilitation program

Detailed Description

The POP-UP study aims to evaluate the feasibility of an 8-week trimodal pre/posthabilitation program (consisting of APA, nutritional assessment, and psychological support) with remote monitoring of the APA sessions and nurse coordination alongside perioperative triplet chemotherapy in patients with localized PDAC (resectable or borderline resectable tumor) or OGC (≥ cT2 or N+).

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 resources/functioning), 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 patient's 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 complications/consequences. There will be a total of three posthabilitation days at hospital during the posthabilitation program.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France
    • Centre Hospitalier Universitaire Dijon Bourgogne
  • Grenoble, France
    • Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble
  • Lille, France
    • Centre Hospitalier Universitaire de Lille
  • Marseille, France
    • Hospital La Timone
  • Reims, France
    • CHU de Reims
  • Rouen, France
    • CENTRE HOSPITALIER UNIVERSITAIRE ROUEN - CHU Charles Nicolle
  • Saint-Cloud, France
    • INSTITUT CURIE de SAint Cloud
  • Saint-Herblain, France
    • Institut de Cancerologie de L'Ouest Rene Gauducheau
  • St-Malo, France
    • Groupe hospitalier Rance Emeraude (CHU Saint-Malo)
  • Tours, France
    • Centre Hospitalier Universitaire Tours - Hopital Trousseau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Signed and dated patient informed consent form (ICF) and willingness to comply with all study procedures and availability for the study duration,
2. Histologically or cytologically proven, localized PDAC or OGC,
3. Indication to a neoadjuvant treatment with triplet chemotherapy for ≥ 4 cycles (8 weeks) validated by the multidisciplinary board, Note: Patient treated for PDAC, dose reduction of oxaliplatin or irinotecan is authorized.
4. Age > 18 years; If aged ≥ 75 years: G8 score must be ≥ 14 and if < 14 validation of oncogeriatric specialist,
5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 at the inclusion visit,
6. No prior treatment for PDAC or OGC before starting chemotherapy (FLOT or FOLFIRINOX),
7. At least one measurable or evaluable lesion as assessed by Computerized Tomography scan or Magnetic resonance imaging according to RECIST 1.1 and feasibility of repeated radiological assessments,
8. Adequate hematologic and end-organ function allowing the triple combination chemotherapy protocol,
9. Registration in a national health care system (PUMa - Protection Universelle Maladie included).

Exclusion Criteria:

1. Evidence of metastatic disease at imaging (validated in multidisciplinary team evaluation),
2. Histology of other than adenocarcinoma,
3. Any medical (including cardiovascular, respiratory, psychiatric, musculoskeletal, or neurological) condition contra-indicating exercise practice,
4. Patients with medical contraindication to surgery due to general condition or comorbidities
5. Pregnancy or breast-feeding,
6. Patient under a legal protection regime (guardianship, curatorship, judicial safeguard) or administrative decision or incapable of giving his/her consent,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Cohort 1 and Cohort 2; Cohort 1 - Patients with PDAC Cohort 2 - Patients with OGC

Other: Prehabilitation program; Cohort 1 - Prehabilitation program will be implemented during the last cycles of neoadjuvant chemotherapy (cycle 5 - cycle 6 or cycle 6 - cycle 8) and the weeks preceding surgery (planned 3-4 weeks after the last chemotherapy cycle) Cohort 2 - Prehabilitation program will be implemented during the last cycles of neoadjuvant chemotherapy (cycle 2 - cycle 4) and the weeks preceding surgery (planned 3-4 weeks after the last chemotherapy cycle)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of eligible patients with successful completion of the 8-week trimodal prehabilitation program	The success of prehabilitation is defined by the achievement of the following three criteria: At least 75% of the (minimum) planned APA sessions, 6 of 8 sessions with an APA professional and 12 of 16 sessions in autonomy with remote APA supervision (note: the total number of APA sessions can be adapted according to the physical activity level of the patient, with a minimum of 8 supervised sessions and 16 autonomy sessions) and; Completion of at least 75% of the nutritional evaluations: 6 of 8 planned evaluations and; Psychological or psychiatric visit before the surgery in function of practice center /resources if a psychological need is shown by Hospital Anxiety and Depression Scale (HADS).	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of APA, nutritional, and psychological interventions	Evaluates completion and adherence of each intervention separately according to predefined success criteria. Unit of Measure: Proportion of patients (%) achieving predefined success criteria	8 weeks
Overall survival (OS) assessment	OS defined as time (months) between the date of inclusion and 12 months after surgery	up to 12 months after surgery
Disease-free survival (DFS) assessment	DFS defined as the time (months) between the date inclusion and the date corresponding at 12 months after surgery	up to 12 months after surgery
Health-related quality of life assessment by EORTC QLQ-C30	HRQoL will be assessed by using the EORTC QLQ-C30 questionnaire at screening, once per month and at the end of intervention visit. The EORTC QLQ-C30 is a cancer specific questionnaire assessing 15 HRQOL scales through 30-items; for each dimension, one score is generated according to the recommendations of the EORTC on a 0-100 scale in order that a high score represents a high functional level, a high Global QoL level, and a high symptomatic level.	8 weeks
Health-related quality of life assessment by EORTC QLQ-PAN26	The EORTC QLQ-PAN26 is a module specific to pancreatic cancer, to be used in conjunction to the EORTC QLQ-C30. It contains 26 items. As for the EORTC QLQ-C30, one score is generated for each score according to the recommendations of the EORTC on a 0-100 scale in order that a high score represents a high functional level and a high symptomatic level.	8 weeks
Health-related quality of life assessment by EORTC QLQ-OG25	The EORTC QLQ-OG25 is a module specific to esophago-gastric cancer to use in conjunction to the EORTC QLQ-C30. It contains 25 items. One score is generated for each score according to the recommendations of the EORTC on a 0-100 scale in order that a high score represents a high functional level and a high symptomatic level	8 weeks
Chemotherapy tolerance assessment	The chemotherapy tolerance with the CTCAE V5.0 (Grade ≥ 3) will be evaluated. Unit of Measure: Number and proportion of patients with Grade ≥3 toxicities (CTCAE v5.0)	8 weeks
Postoperative complications assessment	Major postoperative complications will be measured. Unit of Measure: Number/proportion of patients with Clavien-Dindo Grade ≥3 complications - evaluates serious surgical complications requiring intervention under anesthesia, ICU care, or resulting in death.)	90 days post-surgery
Nurse intervention assessment	The nurse intervention will be evaluated by: Unit of Measure: Number of alerts managed by nurses and oncologists, Weekly remote follow-up completion rate (%), Scheduled vs. completed prehabilitation/posthabilitation sessions (%), and Hospital days	8 weeks
Behavioral changes in physical activity assessment	Daily physical activity will be measured Evaluated using International Physical Activity Questionnaire (IPAQ-S) to assess changes in activity patterns. Unit of Measure: MET-min/week and sitting time (minutes/day)	8 weeks
Adherence to APA program assessment	Tracks patient participation in posthabilitation APA sessions and documents reasons for drop-out. Unit of Measure: Number and proportion of patients completing sessions (%).	8 weeks
Pancreatic function assessment	Fecal elastase and pancreatic enzyme use will be assessed. Unit of Measure: Levels of fecal elastase (µg/g) and pancreatic enzyme consumption (units/day).	8 weeks
G-CSF use and neutropenia assessment	Hematologic support and neutropenia will be evaluated. Unit of Measure: G-CSF prescription (yes/no), rate of grade ≥2 neutropenia (%)	8 weeks
Surgical rate assessment	Surgical rate will be assessed. Unit of Measure: Number/proportion of patients with surgery	8 weeks
Perioperative chemotherapy rate assessment	Assessing completion of scheduled perioperative chemotherapy cycles in eligible patients. Unit of Measure: Number/proportion of patients with planned vs received number of perioperative chemotherapy cycles.	8 weeks
Chemotherapy dose received	Relative dose intensity will be measured. Unit of Measure: Percentage of planned dose received (%)	8 weeks
Nutritional Status Assessment - Body composition	Evaluating changes in skeletal muscle and fat mass to assess nutritional status during the prehabilitation program. Outcome Measure: Skeletal muscle and adipose tissue areas. Unit of Measure: cm² (cross-sectional area at L3 via TAP-CT or bioimpedance)	8 weeks
Nutritional Status Assessment - weight and BMI	Evaluating changes in body weight and BMI to monitor nutritional status. Unit of Measure: kg (weight), kg/m² (BMI).	8 weeks
Nutritional Status Assessment - Food intake	Measuring dietary intake and eating behavior to assess nutritional status. Unit of Measure: Simple Evaluation of Food Intake (SEFI) visual analog scale. The score is reported using the SEFI visual analog scale, which ranges from 0 to 10, where higher scores indicate better food intake.	8 weeks
Nutritional Status Assessment - Serum Albumin evaluation	Evaluating nutritional status through Serum Albumin evaluation. Unit of Measure: g/L. Meaning: Higher albumin levels indicate better nutritional status and overall protein reserves. Interpretation: Good: Higher values (within normal laboratory range) Bad: Lower values (may indicate malnutrition or poor protein intake)	8 weeks
Nutritional Status Assessment - C-Reactive Protein (CRP) evaluation	Evaluating inflammatory status through CRP levels. Unit of Measure: mg/L. CRP is a marker of inflammation. Lower CRP indicates lower inflammatory activity. Interpretation: Good: Lower values (normal or near-normal, minimal inflammation) Bad: Higher values (indicating active inflammation or possible infection)	8 weeks
Nutritional Status Assessment - Complete Blood Count (CBC) Parameters evaluation	Description: Evaluating general health and nutritional status through CBC parameters (e.g., hemoglobin, hematocrit, leukocytes). Unit of Measure: Standard laboratory units (e.g., g/dL for hemoglobin, cells/µL for leukocytes). Meaning: CBC evaluates general health and nutritional status (e.g., hemoglobin for anemia, leukocytes for immune status). Interpretation: Good: Values within normal reference ranges Bad: Values outside normal ranges (e.g., low hemoglobin = anemia, abnormal leukocytes = possible infection or immune dysfunction)	8 weeks
Functional Status Assessment - Physical activity (IPAQ-S)	Assessing daily physical activity using IPAQ-S. It is a 7-item questionnaire in which duration (hours and minutes per day), frequency (times per week), and intensity (walking, moderate and vigorous) of the previous 7 days will be collected. Sedentary time (self-reported time spent sitting) in the same time period will be recorded (hours/min/day).Unit of Measure: MET-min/week and Minutes/day.	8 weeks
Functional Status Assessment - 6-minute walk test	Assessing functional exercise capacity. Outcome Measure: Walking distance (meters).	8 weeks
Functional Status Assessment - Handgrip strength	Assessing upper body muscle strength. Unit of Measure: Kilograms (kg)	8 weeks
Functional Status Assessment - Sit-to-stand test (STS)	Measuring lower limb strength and functional capacity. Unit of Measure: Repetitions per minute	8 weeks
Functional Status Assessment - Borg scale	Measuring subjective exertion during functional tests. Unit of Measure: Score. Score on the Borg scale ranges from 6 (no exertion) to 20 (maximal exertion). Lower scores indicate lighter effort (better functional tolerance), higher scores indicate greater perceived exertion (more strain).	8 weeks
Functional Status Assessment - Balance	Measuring balance and stability. Unit of Measure: Seconds	8 weeks
Functional Status Assessment - Time Up and Go (≥70 years)	Measuring mobility and fall risk in older patients. Unit of Measure: Seconds	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory outcome measure - Changes in imaging assessment	Comparing baseline imaging with preoperative imaging to assess changes in body composition and tumor characteristics, stratified by completion of the prehabilitation program. Unit of Measure: cm² for body composition, mm or cm³ for tumor size	8 weeks
Exploratory outcome measure - Changes in tumor specimen	Evaluating differences between baseline diagnostic biopsy and resected surgical specimen for each patient, stratified by completion of the prehabilitation program. Unit of Measure: Pathologic features (categorical or qualitative).	8 weeks

Collaborators and Investigators

• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
• Investigators: Principal Investigator: Cindy Neuzillet, MD, Institut Curie, Saint-Cloud

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: POP-UP G-128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No