Pancreatic Ductal Adenocarcinoma, Esophageal Cancer
Conditions
Brief summary
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.
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.
Interventions
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)
Sponsors
GERCOR - Multidisciplinary Oncology Cooperative Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Two-cohort, open-label, single-arm feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of eligible patients with successful completion of the 8-week trimodal prehabilitation program | 8 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of APA, nutritional, and psychological interventions | 8 weeks | Evaluates completion and adherence of each intervention separately according to predefined success criteria. Unit of Measure: Proportion of patients (%) achieving predefined success criteria |
| Overall survival (OS) assessment | up to 12 months after surgery | OS defined as time (months) between the date of inclusion and 12 months after surgery |
| Disease-free survival (DFS) assessment | up to 12 months after surgery | DFS defined as the time (months) between the date inclusion and the date corresponding at 12 months after surgery |
| Health-related quality of life assessment by EORTC QLQ-C30 | 8 weeks | 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. |
| Health-related quality of life assessment by EORTC QLQ-PAN26 | 8 weeks | 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. |
| Health-related quality of life assessment by EORTC QLQ-OG25 | 8 weeks | 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 |
| Chemotherapy tolerance assessment | 8 weeks | 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) |
| Postoperative complications assessment | 90 days post-surgery | 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.) |
| Nurse intervention assessment | 8 weeks | 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 |
| Behavioral changes in physical activity assessment | 8 weeks | 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) |
| Adherence to APA program assessment | 8 weeks | Tracks patient participation in posthabilitation APA sessions and documents reasons for drop-out. Unit of Measure: Number and proportion of patients completing sessions (%). |
| Pancreatic function assessment | 8 weeks | Fecal elastase and pancreatic enzyme use will be assessed. Unit of Measure: Levels of fecal elastase (µg/g) and pancreatic enzyme consumption (units/day). |
| G-CSF use and neutropenia assessment | 8 weeks | Hematologic support and neutropenia will be evaluated. Unit of Measure: G-CSF prescription (yes/no), rate of grade ≥2 neutropenia (%) |
| Surgical rate assessment | 8 weeks | Surgical rate will be assessed. Unit of Measure: Number/proportion of patients with surgery |
| Perioperative chemotherapy rate assessment | 8 weeks | 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. |
| Chemotherapy dose received | 8 weeks | Relative dose intensity will be measured. Unit of Measure: Percentage of planned dose received (%) |
| Nutritional Status Assessment - Body composition | 8 weeks | 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) |
| Nutritional Status Assessment - weight and BMI | 8 weeks | Evaluating changes in body weight and BMI to monitor nutritional status. Unit of Measure: kg (weight), kg/m² (BMI). |
| Nutritional Status Assessment - Food intake | 8 weeks | 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. |
| Nutritional Status Assessment - Serum Albumin evaluation | 8 weeks | 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) |
| Nutritional Status Assessment - C-Reactive Protein (CRP) evaluation | 8 weeks | 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) |
| Nutritional Status Assessment - Complete Blood Count (CBC) Parameters evaluation | 8 weeks | 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) |
| Functional Status Assessment - Physical activity (IPAQ-S) | 8 weeks | 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. |
| Functional Status Assessment - 6-minute walk test | 8 weeks | Assessing functional exercise capacity. Outcome Measure: Walking distance (meters). |
| Functional Status Assessment - Handgrip strength | 8 weeks | Assessing upper body muscle strength. Unit of Measure: Kilograms (kg) |
| Functional Status Assessment - Sit-to-stand test (STS) | 8 weeks | Measuring lower limb strength and functional capacity. Unit of Measure: Repetitions per minute |
| Functional Status Assessment - Borg scale | 8 weeks | 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). |
| Functional Status Assessment - Balance | 8 weeks | Measuring balance and stability. Unit of Measure: Seconds |
| Functional Status Assessment - Time Up and Go (≥70 years) | 8 weeks | Measuring mobility and fall risk in older patients. Unit of Measure: Seconds |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORCindy Neuzillet, MD
Institut Curie, Saint-Cloud
Outcome results
None listed