Multidom Remote Monitoring of Patient With Advanced Pancreatic Cancer Treated With Florinox Using the PiCaDo Plateform

Pancreatic cancer is a rapidly developing cancer with a poor prognosis. The mFOLFIRINOX protocol has become the standard medical treatment for this pathology. However, mFOLFIRINOX is the cause of severe toxicities including leukoneutropenia, thrombocytopenia, diarrhea, nausea-vomiting, anorexia, asthenia, weight loss and peripheral sensory neuropathy. Therefore, its indication is limited to patients in good general condition. In practice, it is often interrupted upon the occurrence of hematological and/or clinical grade 3-4 toxicities, Remote patient tele-monitoring of symptoms (Patient Reported Outcomes), body weight, circadian rhythms, sleep and activity would allow the identification of early warning signals reflecting deterioration or improvement in the health of these fragile patients, and trigger proactive interventions, while they are outside the hospital. Thus, the MultiDom study proposes a comprehensive tele-monitoring and telecare strategy that would complement standard of care over a 7-weeks period to 42 consenting patients. The patients receive neoadjuvant or first line chemotherapy with mFOLFIRINOX for advanced or metastatic pancreatic cancer at one of four centres in Ile-de-France region (France).

Sex

All

Minimum age

18 Years

Maximum age

85 Years

Inclusion Criteria:

-Histological or cytological diagnosis of pancreatic adenocarcinoma

* Locally advanced or metastatic pancreatic cancer
* With or without previous surgery (pancreas and / or metastases)
* Performance status of 0 or 1 according to WHO
* Age between 18 and 85 years old included
* No history of prior chemotherapy or radiotherapy
* Absence of cutaneous or mucosal jaundice or skin pruritus
* No proven thrombosis
* Absence of heart disease or other pathology poorly controlled by current treatments
* Bilirubinemia and alkaline phosphatases \<1.5 ULN (with or without stent)
* Hematological, renal and hepatic laboratory tests authorizing the administration of mFOLFIRINOX
* Affiliated subject or beneficiary of a social security scheme
* Patient who freely signed informed consent

Exclusion Criteria:

* Immediately resectable pancreatic cancer
* No histological or cytological evidence of pancreatic adenocarcinoma
* Performance status\> 1 (WHO)
* Age \<18 and\> 85 years old
* Prior administration of chemotherapy or radiotherapy
* Skin jaundice and / or pruritus
* Uncontrolled venous or arterial thrombosis
* Co morbidity not controlled by a specific treatment
* Biological anomalies contraindicating the administration of one or more drugs which make up FOLFIRINOX
* Lack of GPRS coverage in the home
* Patient participating in another clinical study
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant, lactating or parturient woman
* Patient hospitalized without consent.

• BACKGROUNDBouchahda M, Komarzynski S, Ulusakarya A, Attari A, Duprès A, Breda G, Fritsch A, Adam R, Lévi F (2020) Improving FOLFIRINOX safety in pancreatic cancer patients through multidimensional remote monitoring and proactive care using a domomedecine mobile platform. J Clin Oncol 38: TPS4673.
• BACKGROUNDLevi F, Komarzynski S, Huang Q, Young T, Ang Y, Fuller C, Bolborea M, Brettschneider J, Fursse J, Finkenstadt B, White DP, Innominato P. Tele-Monitoring of Cancer Patients' Rhythms during Daily Life Identifies Actionable Determinants of Circadian and Sleep Disruption. Cancers (Basel). 2020 Jul 17;12(7):1938. doi: 10.3390/cancers12071938. PMID 32708950
• BACKGROUNDInnominato P, Komarzynski S, Karaboue A, Ulusakarya A, Bouchahda M, Haydar M, Bossevot-Desmaris R, Mocquery M, Plessis V, Levi F. Home-Based e-Health Platform for Multidimensional Telemonitoring of Symptoms, Body Weight, Sleep, and Circadian Activity: Relevance for Chronomodulated Administration of Irinotecan, Fluorouracil-Leucovorin, and Oxaliplatin at Home-Results From a Pilot Study. JCO Clin Cancer Inform. 2018 Dec;2:1-15. doi: 10.1200/CCI.17.00125. PMID 30652550
• DERIVEDBouchahda M, Ulusakarya A, Thirot-Bidault A, Attari A, Bossevot R, Tuligenga R, Hammel P, Adam R, Levi F. Multicentre, interventional, single-arm study protocol of telemonitored circadian rhythms and patient-reported outcomes for improving mFOLFIRINOX safety in patients with pancreatic cancer (MultiDom, NCT04263948). BMJ Open. 2023 Jun 7;13(6):e069973. doi: 10.1136/bmjopen-2022-069973. PMID 37286324