NCT05414357

Brief Summary

Patients treated for breast cancer frequently complain of sleep disturbances, about 40% of them. Of the sleep disturbances experienced by patients, insomnia is the most common complaint. The prevalence of insomnia complaints is higher in breast cancer patients compared to other types of cancer, and is also higher than in the general population (between 20% and 70% in breast cancer patients vs 30% in the general population). A recent study indicates that sleep complaints concern 25% of patients even before diagnosis, and 46% (including 18% complaining of insomnia) at the time of diagnosis, showing the negative impact of the announcement of the pathology on the subjective quality of sleep, and particularly on symptoms suggestive of insomnia. However, objective information on a modification of sleep patterns in breast cancer remains scarce and does not allow us to conclude. In particular, previous studies have focused only on the effects of chemotherapy and have not always included a control group, limiting the significance of their results. The links with cognitive and psychopathological processes and the underlying mechanisms are not clearly demonstrated in this pathology. Finally, taking into account patients' complaints, it appears necessary to limit sleep disorders in breast cancer in order to improve patients' quality of life using non-medicinal and easy-to-implement approaches.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
15mo left

Started Mar 2023

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Mar 2023Sep 2027

First Submitted

Initial submission to the registry

May 30, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

March 20, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

4 years

First QC Date

May 30, 2022

Last Update Submit

September 17, 2025

Conditions

Breast CancerSleepQuality of Life

Outcome Measures

Primary Outcomes (3)

  • Ratio of total sleep time to time spent in bed and the number of awakenings lasting more than one minute measured by polysomnography with actimeter

    At 6 months

  • Amplitude of activity-rest rhythm measured with actimeter

    At 6 months

  • Acrophase of activity-rest rhythm measured with actimeter

    At 6 months

Study Arms (3)

Patients with chemotherapy

EXPERIMENTAL
Diagnostic Test: Functional Magnetic Resonance Imaging at rest and in activation with attentional task

Patients without chemotherapy

ACTIVE COMPARATOR
Diagnostic Test: Functional Magnetic Resonance Imaging at rest and in activation with attentional task

cancer-free volunteers

ACTIVE COMPARATOR
Diagnostic Test: Functional Magnetic Resonance Imaging at rest and in activation with attentional task

Interventions

Functional Magnetic Resonance Imaging at rest and in activation with attentional taskDIAGNOSTIC_TEST

Participants complete 3 successive assessments (T1: baseline, T2: at 6 months, T3: after galvanic vestibular stimulation). Assessments include: * Functional and Anatomic Magnetic Resonance Imaging at rest and in activation (only at T1 and T2). * Biological and physiological measurements * Spatial memory task * Cognitive battery * Questionnaires (sleep, quality of life)

Also known as: Spatial memory task, Cognitive battery, quality of life questionnaires
Patients with chemotherapyPatients without chemotherapycancer-free volunteers

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 39 to 69 years
  • Patient with operated localized breast cancer who may or may not be starting adjuvant chemotherapy
  • Patient with education level 3 "end of primary education"
  • Patient with a good command of the French language
  • Patient with access to the Internet from a computer at home
  • Patient having signed the consent to participate in the study
  • Patient with no pre-existing cognitive impairment at the time of cancer diagnosis
  • Patient with a sleep complaint (ISI \> 7)

You may not qualify if:

  • Patient with metastatic cancer
  • Patient with a primary cancer other than breast cancer
  • Patient with a history of neurological damage
  • Patient with treated sleep apnea
  • Patient with drug use or alcohol abuse (≥3 drinks/day on average and/or \>10 drinks/week)
  • Patient with a treatment that has not been stabilized for at least 3 months (hypnotics, antidepressants, anxiolytics)
  • Patient with a personality disorder and/or an evolving psychiatric pathology
  • Patient with a contraindication to MRI (claustrophobia, metallic objects in the body)
  • Patient with an uncorrected vision problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre François Baclesse

Caen, 14000, France

RECRUITING

Inserm-Ephe-Unicaen U1077

Caen, 14000, France

NOT YET RECRUITING

Related Publications (2)

  • Galin M, de Girolamo L, Clarisse B, Segura-Djezzar C, Glockner F, Elia C, Rehel S, Clochon P, Doidy F, Chavant J, Etard O, Viader F, Grellard JM, Lequesne J, Joly F, Eustache F, Martin T, Giffard B, Quarck G, Perrier J. Exploration of effects of galvanic vestibular stimulation on circadian rhythms and its associations with sleep and spatial memory in patients with breast cancer: The ICANSLEEP-2 protocol. PLoS One. 2024 Jul 31;19(7):e0306462. doi: 10.1371/journal.pone.0306462. eCollection 2024.

    PMID: 39083526DERIVED

  • Elia C, de Girolamo L, Clarisse B, Galin M, Rehel S, Clochon P, Doidy F, Segobin S, Viader F, Naveau M, Delcroix N, Segura-Djezzar C, Grellard JM, Lequesne J, Etard O, Martin T, Quarck G, Eustache F, Joly F, Giffard B, Perrier J. Effects of sleep disturbances and circadian rhythms modifications on cognition in breast cancer women before and after adjuvant chemotherapy: the ICANSLEEP-1 protocol. BMC Cancer. 2023 Dec 1;23(1):1178. doi: 10.1186/s12885-023-11664-x.

    PMID: 38041077DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Carine SEGURA-DJEZZAR, MD

CONTACT

+33 2 31 45 50 02c.segura.djezzar@baclesse.unicancer.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2022

First Posted

June 10, 2022

Study Start

March 20, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)