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

NCT04263948 | Completed DMC

• 1 other identifier: 2017-12-033
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Pancreas Cancer

Keywords

pancreas cancer; Plateform monitoring; metastatic or "borderline"; telemedicine; tele monitoring; telecare; emergency hospitalisations; patient-centered medicine; internet platform; circadian rhythms; chronotherapy; physical activity; sleep; patient -reported outcomes; symptoms; quality of life; compliance; sensors; electronic questionnaires

Outcome Measures

Primary Outcomes (2)

• Toxicity-related emergency hospitalisation rate

  The main objective is to assess the toxicities occurring during the 6 weeks following the start of the 1st cycle of FOLFIRINOX in conventional administration in patients benefiting from the PiCADo telemonitoring system.

  First cycle of treatment of 6 weeks

• Rates and grades toxicity and early tumor responses

  Secondary objectives include rates and grades of toxicity and early tumor responses, as well as PiCADo platform performances and users perceptions.

  First cycle of treatment of 6 weeks

Study Arms (1)

Picado Arm

EXPERIMENTAL

All the patients undergo multidimensional tele monitoring for 7 weeks using an upgraded version of the Picado internet platform

Device: Picado system internet platform and connected objects

Interventions

Picado system internet platform and connected objects DEVICE

The system will monitor the circadian rhythms, physical activity, sleep, symptoms and body weight of patients with advanced pancreatic cancer during one week before (baseline) and six weeks after the 1st course of standard mFOLFIRINOX. The reach of preset thresholds for several parameters that are automatically computed will trigger alerts toward approved health professionals, and their responses will be traced.

Picado Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• Faculty of Medicine Paris Saclay University: collaborator
• Altran: collaborator
• Assistance Publique - Hôpitaux de Paris: collaborator

Study Sites (1)

Clinique du Mousseau

Évry, IDF, 91000, France

Location

Related Publications (4)

• Bouchahda 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.

  BACKGROUND

• Levi 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 BACKGROUND

• Innominato 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 BACKGROUND

• Bouchahda 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 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis; Motor Activity; Patient Compliance

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 11, 2020
• Study Start: June 1, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available for two years following article publication at jf.oudet@ecten.eu.
• Access Criteria: Access will be granted to researchers who provide a methodologically sound proposal and only aim toward publicly available scientific publication, and in accordance with the French General Data Protection Regulation."

Locations

FR (1)