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

Pancreas Cancer Clinical Trial

— MULTIDOM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04263948
• Other study ID #: 2017-12-033
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: Ramsay Générale de Santé
• Contact: JEAN FRANÇOIS OUDET
• Phone: 0683346567
• Email: jeanfrancois.oudet[@]free.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

MultiDom stands up among the very first prospective patient-entered and multidimensional, multiactor and multicenter study, that assesses the qualitative and quantitative impact of mFOLFIRINOX on the daily life of patients with pancreatic cancer in real time. Main endpoint is the rate of patients undergoing toxicity-related emergency hospitalisations, and the objective is to reduce it to <10%. Telemonitored data-based proactive interventions will expectedly prevent worsening of patients 'health, and maintain their chances of disease control on effective mFOLFIRINOX chemotherapy.

Participating patients have usual follow up and treatments for their disease, but also: wear a chest sensor that measures and teletransmits accelerometry, surface temperature and 3D-orientation every min, weigh themselves daily on a BLE-balance, with immediate weight tele transmission, and fill out electronic PRO questionnaires daily using a telecommunicating tablet.

All data are tele transmitted to an approved health data hub, and automatically analysed for physical activity, sleep, circadian rhythms, symptoms scores trends in real time. Visualization screens and alerts are generated according to preset thresholds, and medical team responses are traced.

Currently recruiting centres:

1. Clinique du Mousseau, Evry, France

2. Hospital Paul Brousse (Assistance Publique-Hôpitaux de Paris), Villejuif, France

3. Clinique St-Jean L'Ermitage, Melun, France

4. Private Hospital of Antony, Antony, France

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 31, 2025
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Device:
• Picado system internet platform and connected objects
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.

Locations

Country	Name	City	State
France	Clinique du Mousseau	Évry	IDF

Sponsors (4)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	Altran, Assistance Publique - Hôpitaux de Paris, Faculty of Medicine Paris Saclay University

Country where clinical trial is conducted

France, 

References & Publications (3)

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.

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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