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.
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
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
9
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)
Centre Hospitalier Universitaire Dijon Bourgogne
Dijon, France
Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble
Grenoble, France
Centre Hospitalier Universitaire de Lille
Lille, France
Hospital La Timone
Marseille, France
CHU de Reims
Reims, France
CENTRE HOSPITALIER UNIVERSITAIRE ROUEN - CHU Charles Nicolle
Rouen, France
INSTITUT CURIE de SAint Cloud
Saint-Cloud, France
Institut de Cancerologie de L'Ouest Rene Gauducheau
Saint-Herblain, France
Groupe hospitalier Rance Emeraude (CHU Saint-Malo)
St-Malo, France
Centre Hospitalier Universitaire Tours - Hopital Trousseau
Tours, France
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: 1. 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 2. Completion of at least 75% of the nutritional evaluations: 6 of 8 planned evaluations and 3. 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).
Time frame: 8 weeks
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
Time frame: 8 weeks
Overall survival (OS) assessment
OS defined as time (months) between the date of inclusion and 12 months after surgery
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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.)
Time frame: 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
Time frame: 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)
Time frame: 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 (%).
Time frame: 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).
Time frame: 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 (%)
Time frame: 8 weeks
Surgical rate assessment
Surgical rate will be assessed. Unit of Measure: Number/proportion of patients with surgery
Time frame: 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.
Time frame: 8 weeks
Chemotherapy dose received
Relative dose intensity will be measured. Unit of Measure: Percentage of planned dose received (%)
Time frame: 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)
Time frame: 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).
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 8 weeks
Functional Status Assessment - 6-minute walk test
Assessing functional exercise capacity. Outcome Measure: Walking distance (meters).
Time frame: 8 weeks
Functional Status Assessment - Handgrip strength
Assessing upper body muscle strength. Unit of Measure: Kilograms (kg)
Time frame: 8 weeks
Functional Status Assessment - Sit-to-stand test (STS)
Measuring lower limb strength and functional capacity. Unit of Measure: Repetitions per minute
Time frame: 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).
Time frame: 8 weeks
Functional Status Assessment - Balance
Measuring balance and stability. Unit of Measure: Seconds
Time frame: 8 weeks
Functional Status Assessment - Time Up and Go (≥70 years)
Measuring mobility and fall risk in older patients. Unit of Measure: Seconds
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.