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

NCT04263948 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-10-03

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Faculty of Medicine Paris Saclay University

    collaborator UNKNOWN

  • Altran

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    collaborator OTHER

  • Ramsay Générale de Santé

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04263948 on ClinicalTrials.gov