Effects of sleep disturbances and circadian rhythms modifications on cognition in breast cancer women before and after adjuvant chemotherapy: the ICANSLEEP-1 protocol.


Journal

BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800

Informations de publication

Date de publication:
01 Dec 2023
Historique:
received: 05 07 2023
accepted: 21 11 2023
medline: 4 12 2023
pubmed: 2 12 2023
entrez: 1 12 2023
Statut: epublish

Résumé

Many patients treated for breast cancer (BC) complain about cognitive difficulties affecting their daily lives. Recently, sleep disturbances and circadian rhythm disruptions have been brought to the fore as potential contributors to cognitive difficulties in patients with BC. Yet, studies on these factors as well as their neural correlates are scarce. The purpose of the ICANSLEEP-1 (Impact of SLEEP disturbances in CANcer) study is to characterize sleep using polysomnography and its relationship with the evolution of cognitive functioning at both the behavioral and the neuroanatomical levels across treatment in BC patients treated or not with adjuvant chemotherapy. ICANSLEEP-1 is a longitudinal study including BC patients treated with adjuvant chemotherapy (n = 25) or not treated with adjuvant chemotherapy (n = 25) and healthy controls with no history of BC (n = 25) matched for age (45-65 years old) and education level. The evaluations will take place within 6 weeks after inclusion, before the initiation of chemotherapy (for BC patients who are candidates for chemotherapy) or before the first fraction of radiotherapy (for BC patients with no indication for chemotherapy) and 6 months later (corresponding to 2 weeks after the end of chemotherapy). Episodic memory, executive functions, psychological factors, and quality of life will be assessed with validated neuropsychological tests and self-questionnaires. Sleep quantity and quality will be assessed with polysomnography and circadian rhythms with both actigraphy and saliva cortisol. Grey and white matter volumes, as well as white matter microstructural integrity, will be compared across time between patients and controls and will serve to further investigate the relationship between sleep disturbances and cognitive decline. Our results will help patients and clinicians to better understand sleep disturbances in BC and their relationship with cognitive functioning across treatment. This will aid the identification of more appropriate sleep therapeutic approaches adapted to BC patients. Improving sleep in BC would eventually help limit cognitive deficits and thus improve quality of life during and after treatments. NCT05414357, registered June 10, 2022. Version 1.2 dated March 23, 2022.

Sections du résumé

BACKGROUND BACKGROUND
Many patients treated for breast cancer (BC) complain about cognitive difficulties affecting their daily lives. Recently, sleep disturbances and circadian rhythm disruptions have been brought to the fore as potential contributors to cognitive difficulties in patients with BC. Yet, studies on these factors as well as their neural correlates are scarce. The purpose of the ICANSLEEP-1 (Impact of SLEEP disturbances in CANcer) study is to characterize sleep using polysomnography and its relationship with the evolution of cognitive functioning at both the behavioral and the neuroanatomical levels across treatment in BC patients treated or not with adjuvant chemotherapy.
METHODS METHODS
ICANSLEEP-1 is a longitudinal study including BC patients treated with adjuvant chemotherapy (n = 25) or not treated with adjuvant chemotherapy (n = 25) and healthy controls with no history of BC (n = 25) matched for age (45-65 years old) and education level. The evaluations will take place within 6 weeks after inclusion, before the initiation of chemotherapy (for BC patients who are candidates for chemotherapy) or before the first fraction of radiotherapy (for BC patients with no indication for chemotherapy) and 6 months later (corresponding to 2 weeks after the end of chemotherapy). Episodic memory, executive functions, psychological factors, and quality of life will be assessed with validated neuropsychological tests and self-questionnaires. Sleep quantity and quality will be assessed with polysomnography and circadian rhythms with both actigraphy and saliva cortisol. Grey and white matter volumes, as well as white matter microstructural integrity, will be compared across time between patients and controls and will serve to further investigate the relationship between sleep disturbances and cognitive decline.
DISCUSSION CONCLUSIONS
Our results will help patients and clinicians to better understand sleep disturbances in BC and their relationship with cognitive functioning across treatment. This will aid the identification of more appropriate sleep therapeutic approaches adapted to BC patients. Improving sleep in BC would eventually help limit cognitive deficits and thus improve quality of life during and after treatments.
TRIAL REGISTRATION BACKGROUND
NCT05414357, registered June 10, 2022.
PROTOCOL VERSION METHODS
Version 1.2 dated March 23, 2022.

Identifiants

pubmed: 38041077
doi: 10.1186/s12885-023-11664-x
pii: 10.1186/s12885-023-11664-x
pmc: PMC10693085
doi:

Banques de données

ClinicalTrials.gov
['NCT05414357']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1178

Subventions

Organisme : Université de Caen Normandie
ID : Doctoral Contract
Organisme : Région Normandie
ID : Chair of excellence 2020
Organisme : Fondation ARC pour la Recherche sur le Cancer
ID : ARCPJA2021060003783

Informations de copyright

© 2023. The Author(s).

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Auteurs

Clara Elia (C)

Normandie Univ, UNICAEN, PSL Université, EPHE, INSERM, U1077, CHU de Caen, GIP Cyceron, Neuropsychologie et Imagerie de la Mémoire Humaine, Caen, 14000, France.

Laura de Girolamo (L)

Normandie Univ, UNICAEN, PSL Université, EPHE, INSERM, U1077, CHU de Caen, GIP Cyceron, Neuropsychologie et Imagerie de la Mémoire Humaine, Caen, 14000, France.

Bénédicte Clarisse (B)

Clinical Research Department, Centre François Baclesse, Caen, 14076, France.

Melvin Galin (M)

Normandie Univ, UNICAEN, PSL Université, EPHE, INSERM, U1077, CHU de Caen, GIP Cyceron, Neuropsychologie et Imagerie de la Mémoire Humaine, Caen, 14000, France.
Normandie Université, UNICAEN, INSERM, COMETE U1075, CYCERON, CHU Caen, Caen, 14000, France.

Stéphane Rehel (S)

Normandie Univ, UNICAEN, PSL Université, EPHE, INSERM, U1077, CHU de Caen, GIP Cyceron, Neuropsychologie et Imagerie de la Mémoire Humaine, Caen, 14000, France.

Patrice Clochon (P)

Normandie Univ, UNICAEN, PSL Université, EPHE, INSERM, U1077, CHU de Caen, GIP Cyceron, Neuropsychologie et Imagerie de la Mémoire Humaine, Caen, 14000, France.

Franck Doidy (F)

Normandie Univ, UNICAEN, PSL Université, EPHE, INSERM, U1077, CHU de Caen, GIP Cyceron, Neuropsychologie et Imagerie de la Mémoire Humaine, Caen, 14000, France.

Shailendra Segobin (S)

Normandie Univ, UNICAEN, PSL Université, EPHE, INSERM, U1077, CHU de Caen, GIP Cyceron, Neuropsychologie et Imagerie de la Mémoire Humaine, Caen, 14000, France.

Fausto Viader (F)

Normandie Univ, UNICAEN, PSL Université, EPHE, INSERM, U1077, CHU de Caen, GIP Cyceron, Neuropsychologie et Imagerie de la Mémoire Humaine, Caen, 14000, France.
Neurology Department, CHU de Caen, Caen, 14000, France.

Mikaël Naveau (M)

Normandie Université, UNICAEN, CNRS UAR 3408, INSERM US-50, GIP Cyceron, Caen, France.

Nicolas Delcroix (N)

Normandie Université, UNICAEN, CNRS UAR 3408, INSERM US-50, GIP Cyceron, Caen, France.

Carine Segura-Djezzar (C)

Medical Oncology Department, Centre François Baclesse, Caen, 14076, France.

Jean-Michel Grellard (JM)

Clinical Research Department, Centre François Baclesse, Caen, 14076, France.

Justine Lequesne (J)

Clinical Research Department, Centre François Baclesse, Caen, 14076, France.

Olivier Etard (O)

Normandie Université, UNICAEN, INSERM, COMETE U1075, CYCERON, CHU Caen, Caen, 14000, France.

Tristan Martin (T)

Faculty of Sciences and Technologies, Le Mans University, Avenue Olivier Messiaen, Movement, Interactions, Performance, Le Mans, 4334, 72000, MIP, EA, France.

Gaëlle Quarck (G)

Normandie Université, UNICAEN, INSERM, COMETE U1075, CYCERON, CHU Caen, Caen, 14000, France.

Francis Eustache (F)

Normandie Univ, UNICAEN, PSL Université, EPHE, INSERM, U1077, CHU de Caen, GIP Cyceron, Neuropsychologie et Imagerie de la Mémoire Humaine, Caen, 14000, France.

Florence Joly (F)

Clinical Research Department, Centre François Baclesse, Caen, 14076, France.
Cancer and Cognition Platform, Ligue Nationale Contre le Cancer, Caen, 14076, France.
ANTICIPE (Interdisciplinary Research Unit for the Prevention and Treatment of Cancer), INSERM Unit 1086, Caen, France.

Bénédicte Giffard (B)

Normandie Univ, UNICAEN, PSL Université, EPHE, INSERM, U1077, CHU de Caen, GIP Cyceron, Neuropsychologie et Imagerie de la Mémoire Humaine, Caen, 14000, France.
Cancer and Cognition Platform, Ligue Nationale Contre le Cancer, Caen, 14076, France.
Pôle des Formations et de Recherche en Santé, 2 rue des Rochambelles, Caen Cedex, CS-14032, France.

Joy Perrier (J)

Normandie Univ, UNICAEN, PSL Université, EPHE, INSERM, U1077, CHU de Caen, GIP Cyceron, Neuropsychologie et Imagerie de la Mémoire Humaine, Caen, 14000, France. joy.perrier@unicaen.fr.

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