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.
Signed and dated patient informed consent form (ICF) and willingness to comply with all study procedures and availability for the study duration,
Histologically or cytologically proven, localized PDAC or OGC,
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.
Age > 18 years; If aged ≥ 75 years: G8 score must be ≥ 14 and if < 14 validation of oncogeriatric specialist,
Evidence of metastatic disease at imaging (validated in multidisciplinary team evaluation),
Histology of other than adenocarcinoma,
Any medical (including cardiovascular, respiratory, psychiatric, musculoskeletal, or neurological) condition contra-indicating exercise practice,
Patients with medical contraindication to surgery due to general condition or comorbidities
Single group
Prehabilitation program
Other interventionCohort 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)
The feasibility of personalized, 8-week trimodal pre-habilitation program alongside perioperative triplet chemotherapy
The success of pre-habilitation 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).
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
Overall survival (OS) assessment
OS defined as time (months) between the date of inclusion and 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
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.
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
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).
Click on the lead sponsor to view all of their trials.
