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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 and Cohort 2 | Other | Cohort 1 - Patients with PDAC Cohort 2 - Patients with OGC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation program | Other | 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) |
| 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:
| 8 weeks |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cindy Neuzillet, MD | Institut Curie, Saint-Cloud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Dijon Bourgogne | Dijon | France | ||||
| Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble |
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Two-cohort, open-label, single-arm feasibility study
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|
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 |
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 |
| 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 |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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