Clinical trial NCT06275737: POP-UP: a Single-arm, Two-cohort Study: Trimodal Prehab for Upper GI and Pancreatic Cancer
Official title: Trimodal Peri Operative Prehabilitation for Upper Oesogastric and Pancreatic Cancer: A Multicenter, Two-cohort, Open-label, Single-arm POP-UP GERCOR Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Ductal Adenocarcinoma
Esophageal Cancer
Lead sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Two-cohort, open-label, single-arm feasibility study
Primary purpose: OTHER

Brief summary: This is a multicenter, two-cohort, open-label, single-arm feasibility study. The primary objective is to assess the feasibility of the 8-week trimodal prehabilitation program alongside perioperative triplet chemotherapy in eligible patients with localized pancreatic ductal adenocarcinoma (PDAC) or oesogastric cancer (OGC) .

Detailed description: The POP-UP study aims to evaluate the feasibility and preliminary efficacy of an 8-week trimodal pre/posthabilitation program (consisting of personalized Adapted Physical Activity \[APA\], nutritional assessment, and psychological support) with remote monitoring of the APA sessions and nurse coordination in patients with localized (resectable or borderline resectable) PDAC who are treated with neoadjuvant or induction treatment (FOLFIRINOX: 5-fluorouracil/folinic acid, oxaliplatin, irinotecan) prior to surgery and with resectable OGC treated with perioperative chemotherapy (FLOT: 5-fluorouracil/folinic acid, oxaliplatin, docetaxel).

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.

Eligibility criteria: Inclusion Criteria:

* 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 localized PDAC or OGC validated by the multidisciplinary team,
* Indication to a preoperative treatment withtriplet chemotherapy for ≥ 4 cycles (8 weeks), Note: Patient treated for PDAC, first cycle without oxaliplatin is authorized.
* Age \> 18 years; If aged ≥ 75 years: G8 score must be ≥ 14 and if \< 14 validation of oncogeriatric specialist,
* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 at inclusion visit (first prehabilitation hospital-day),
* No prior treatment for PDAC or OGC before screening visit,
* 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 on baseline imaging before starting chemotherapy,
* Adequate hematologic and end-organ function allowing the triple combination chemotherapy protocol,
* Registration in a national health care system (PUMa - Protection Universelle Maladie included).

Exclusion Criteria:

* 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
* Pregnancy or breast-feeding,
* Patient under a legal protection regime (guardianship, curatorship, judicial safeguard) or administrative decision or incapable of giving his/her consent,

Primary outcomes:
measure: Rate of patients with successful completion of an 8-week trimodal prehabilitation program
timeFrame: 8 weeks
Secondary outcomes:
measure: Success rate (as defined above) for Adapted Physical Activity (APA), nutritional, and psychological interventions measured separately.
timeFrame: 8 weeks
measure: Health-related quality of life (HRQoL) assessment
timeFrame: Up to 3 years
measure: Rate of patients who start and complete post-habilitation Adapted Physical Activity (APA) sessions
timeFrame: 8 weeks
measure: Nutritional status assessment
timeFrame: 8 weeks
measure: Physical/functional test assessment
timeFrame: 8 weeks
measure: Number of patients with reduced chemotherapy tolerance
timeFrame: 8 weeks
measure: Number of patients with chemotherapy dose modification
timeFrame: 8 weeks
measure: Rate of patients who complete the strategy
timeFrame: 8 weeks
measure: Number of patients with Granulocyte-colony stimulating factor (G-CSF) prescription and grade ≥ 2 neutropenia
timeFrame: 8 weeks
measure: Rate of patients with exocrine pancreatic insufficiency and the dose of pancreatic enzyme consumption
timeFrame: 8 weeks
measure: Rate of surgical complications
timeFrame: At 30 days after surgery
measure: Overall survival (OS) assessment
timeFrame: From inclusion up to 12 months after surgery
measure: Disease-free survival (DFS) assessment
timeFrame: From inclusion up to 12 months after surgery
measure: Adherence to Adapted Physical Activity (APA) program assessment
timeFrame: 8 weeks
measure: Physical activity behavior changes assessment
timeFrame: 8 weeks
measure: Nurse coordination
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Saint-Cloud
country: France
facility: Institut Curie
city: Saint-Herblain
country: France
facility: Institut de Cancerologie de L'Ouest Rene Gauducheau
Study officials:
affiliation: Institut Curie, Saint-Cloud
name: Cindy Neuzillet, MD
role: PRINCIPAL_INVESTIGATOR
References: