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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)
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Bouchahda, Mohamed, Ulusakarya, Ayhan, Thirot-Bidault, Anne, Attari, Amal, Bossevot, Rachel, Tuligenga, Richard, Hammel, Pascal, Adam, René and Lévi, Francis A. (2023) 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, 13 (6). e069973. doi:10.1136/bmjopen-2022-069973 ISSN 2044-6055.
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Official URL: https://doi.org/10.1136/bmjopen-2022-069973
Abstract
Introduction: Circadian clocks regulate cellular proliferation and drug effects. Tolerability and/or efficacy of anticancer therapies have been improved by their administration according to circadian rhythms, while being predicted by circadian robustness. The combination of leucovorin, fluorouracil, irinotecan and oxaliplatin (mFOLFIRINOX) is a standard treatment for pancreatic ductal adenocarcinoma (PDAC), that generates grades 3–4 adverse events in the majority of patients and an estimated 15%–30% emergency admission rate. The MultiDom study evaluates whether mFOLFIRINOX safety can be improved using a novel circadian-based telemonitoring-telecare platform in patients at home. The detection of early warning signals of clinical toxicities could guide their early management, possibly preventing emergency hospital admissions. Methods and analysis: This multicentre, interventional, prospective, longitudinal, single-arm study hypothesises that the mFOLFIRINOX-related emergency admission rate will be 5% (95% CI 1.7% to 13.7%), among 67 patients with advanced PDAC. Study participation is 7 weeks for each patient, including a reference week before chemotherapy onset and 6 weeks afterwards. Accelerometry and body temperature are measured q1-min using a continuously worn telecommunicating chest surface sensor, daily body weight is self-measured with a telecommunicating balance and 23 electronic patient-reported outcomes (e-PROs) are self-rated using a tablet. Hidden Markov model, spectral analyses and other algorithms automatically compute physical activity, sleep, temperature, body weight change, e-PRO severity and 12 circadian sleep/activity parameters, including the dichotomy index I<O (% activity ‘in-bed’ below median activity ‘out-of-bed’), once to four times daily. Health professionals access visual displays of near-real time parameter dynamics and receive automatic alerts, with trackable digital follow-up. Ethics and dissemination: The study has been approved by the National Agency for Medication and Health Product Safety (ANSM) and Ethics Committee West V (2 July 2019; third amendment, 14 June 2022). The data will be disseminated at conferences and in peer-reviewed journals and will support large-scale randomised evaluation. Trial registration numbers: NCT04263948 and ID RCB-2019-A00566-51.
Item Type: | Journal Article | ||||||
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Subjects: | Q Science > QP Physiology R Medicine > R Medicine (General) R Medicine > RC Internal medicine R Medicine > RM Therapeutics. Pharmacology |
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School | ||||||
SWORD Depositor: | Library Publications Router | ||||||
Library of Congress Subject Headings (LCSH): | Pancreas -- Cancer, Pancreas -- Cancer -- Treatment, Chemotherapy, Circadian rhythms, Circadian rhythms -- Therapeutic use, Telecommunication in medicine | ||||||
Journal or Publication Title: | BMJ Open | ||||||
Publisher: | BMJ Publishing Group | ||||||
ISSN: | 2044-6055 | ||||||
Official Date: | 7 June 2023 | ||||||
Dates: |
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Volume: | 13 | ||||||
Number: | 6 | ||||||
Article Number: | e069973 | ||||||
DOI: | 10.1136/bmjopen-2022-069973 | ||||||
Status: | Peer Reviewed | ||||||
Publication Status: | Published | ||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||
Date of first compliant deposit: | 21 July 2023 | ||||||
Date of first compliant Open Access: | 21 July 2023 | ||||||
RIOXX Funder/Project Grant: |
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