Remote monitoring for patients with advanced pancreatic cancer receiving mFOLFIRINOX treatment
Multidom Remote Monitoring of Patient With Advanced Pancreatic Cancer Treated With Florinox Using the PiCaDo Domomedecine Plateform
This study is testing whether using remote monitoring tools can help patients with advanced pancreatic cancer on mFOLFIRINOX treatment manage their symptoms better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Ramsay Générale de Santé Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Évry, IDF) |
| Trial ID | NCT04263948 on ClinicalTrials.gov |
What this trial studies
This study focuses on the remote monitoring of patients with advanced pancreatic cancer who are being treated with the mFOLFIRINOX chemotherapy regimen. Utilizing the PiCaDo platform, patients will wear sensors to track their physical activity, body temperature, and other health metrics, while also reporting symptoms through electronic questionnaires. The goal is to proactively identify and manage treatment-related toxicities, thereby reducing emergency hospitalizations and improving overall patient outcomes. The study aims to assess the impact of this tele-monitoring approach on the quality of life and health management of these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 85 with a histological diagnosis of locally advanced or metastatic pancreatic adenocarcinoma and a performance status of 0 or 1.
Not a fit: Patients with immediately resectable pancreatic cancer or those with a performance status greater than 1 may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce hospitalizations due to chemotherapy-related toxicities and improve the quality of life for patients with advanced pancreatic cancer.
How similar studies have performed: While the use of tele-monitoring in cancer care is gaining traction, this specific multidimensional approach in pancreatic cancer treatment is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Évry, IDF
- Clinique du Mousseau — Évry, Idf, France (Recruiting)
Study contacts
- Study coordinator: Jean François Oudet
- Email: jeanfrancois.oudet@free.fr
- Phone: 0683346567
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.