Breast CancerPROSOM-KNCT03420105
Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep
A study testing Neuropsychological, psycho-pathological and quality of life assessments and Hormonotherapy in people with Breast Cancer and Memory Disorders, run by Centre Francois Baclesse at 2 sites in France.
Trial summary
The results of this study will contribute to a better understanding of prospective memory deficit processes in breast cancer in relation to sleep disorders frequently reported in this pathology. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Memory Disorders
- What is being tested?
- Neuropsychological, psycho-pathological and quality of life assessments and Hormonotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Jan 2018to 6 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Major patients under the age of 70;
- Patients who have been treated by surgery or radiotherapy for non-metastatic breast cancer
- Radiotherapy completed for about 6 months
- Level of study 3 "end of primary studies" minimum (Barbizet scale);
- French mother tongue;
- Menopausal women for at least 1 year before the selection visit
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- Absence of primary cancer of the central nervous system or brain metastases;
- Absence of previous neurological damage;
- Absence of personality disorders and progressive psychiatric pathology;
- Having signed the informed consent to participate in the study.
Who cannot join
- Primary cancer other than breast
- Metastatic cancer
- Treated by chemotherapy
- Cognitive function disorders pre-existing to cancer diagnosis
- Patients with paraneoplastic syndrome;
- Evolutionary psychiatric pathology;
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- Refusal of participation;
- Patients unable to respond to cognitive tests;
- Drug use or excessive consumption of alcohol.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre François Baclesse
Caen, 14076
Inserm-Ephe-Unicaen U1077 (
Caen
About this study
The results of this study will contribute to a better understanding of prospective memory deficit processes in breast cancer in relation to sleep disorders frequently reported in this pathology. In the long term, a better understanding will make it possible to envisage appropriate treatments to compensate for these memory difficulties and to improve the autonomy of the patients.
- Conditions
- Breast Cancer, Memory Disorders
- Being tested
- Neuropsychological, psycho-pathological and quality of life assessments, Hormonotherapy
- Medical subject headings
- Breast Neoplasms, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological, psycho-pathological and quality of life assessmentsOther
Also called sleep tests
Patients and Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests
HormonotherapyDrug
Adjuvant hormone therapy
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Patients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests Receives: Other: Neuropsychological, psycho-pathological and quality of life assessments; Drug: Hormonotherapy |
| Group B | Other | Patients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests Receives: Other: Neuropsychological, psycho-pathological and quality of life assessments |
| Healthy volunteers | Other | Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests Receives: Other: Neuropsychological, psycho-pathological and quality of life assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
The memory components and memory loss mechanisms by questionnaires
Measured: 6 months after the end of radiotherapy
Secondary outcomes (3)
The effect of sleep quality on the recovery of intentions in prospective memory by questionnaires
Measured: 6 months after the end of radiotherapy
The impact of adjuvant hormone therapy on the functioning of prospective memory by questionnaires
Measured: 6 months after the end of radiotherapy
The influence of anxio-depressive factors and fatigue on prospective memory by questionnaires
Measured: 6 months after the end of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start5 Jan 2018
- Primary completion6 Mar 2020
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 50 patients including: * 25 patients being treated with adjuvant hormone therapy (Group A) * 25 patients not receiving adjuvant hormone therapy (Group B) * 25 healthy volunteers
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420105
- Sponsor's protocol ID
- PROSOM-K
- Acronym
- PROSOM-K
- Status last verified
- Feb 2020
- First submitted
- 10 Jan 2018
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elia C, Perrier J, Duivon M, Rehel S, Gernier F, Fernette M, Doidy F, Clochon P, Grellard JM, Christy F, Segura-Djezzar C, Geffrelot J, Emile G, Allouache D, Viader F, Levy C, Joly F, Eustache F, Giffard B. Links between nocturnal hypoxia and cognitive function in breast cancer. Sci Rep. 2025 Nov 27;15(1):42405. doi: 10.1038/s41598-025-26591-z.
PubMed 41309988Duivon M, Perrier J, Joly F, Licaj I, Grellard JM, Clarisse B, Levy C, Fleury P, Madeleine S, Lefevre N, Rauchs G, Lecouvey G, Fraisse F, Viader F, Eustache F, Desgranges B, Giffard B. Impact of breast cancer on prospective memory functioning assessed by virtual reality and influence of sleep quality and hormonal therapy: PROSOM-K study. BMC Cancer. 2018 Sep 3;18(1):866. doi: 10.1186/s12885-018-4762-2.
PubMed 30176833
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep
- ClinicalTrials.gov ID
- NCT03420105
- Acronym / sponsor ID
- PROSOM-K / PROSOM-K
- Conditions
- Breast Cancer, Memory Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The results of this study will contribute to a better understanding of prospective memory deficit processes in breast cancer in relation to sleep disorders frequently reported in this pathology. In the long term, a better understanding will make it possible to envisage appropriate treatments to compensate for these memory difficulties and to improve the autonomy of the patients.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 50 patients including: * 25 patients being treated with adjuvant hormone therapy (Group A) * 25 patients not receiving adjuvant hormone therapy (Group B) * 25 healthy volunteers
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Other: Neuropsychological, psycho-pathological and quality of life assessments, Drug: HormonotherapyPatients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests |
| Group B | Other | Other: Neuropsychological, psycho-pathological and quality of life assessmentsPatients perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests |
| Healthy volunteers | Other | Other: Neuropsychological, psycho-pathological and quality of life assessmentsHealthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Major patients under the age of 70;
- Patients who have been treated by surgery or radiotherapy for non-metastatic breast cancer
- Radiotherapy completed for about 6 months
- Level of study 3 "end of primary studies" minimum (Barbizet scale);
- French mother tongue;
Key exclusion criteria (9 listed)
- Primary cancer other than breast
- Metastatic cancer
- Treated by chemotherapy
- Cognitive function disorders pre-existing to cancer diagnosis
- Patients with paraneoplastic syndrome;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological, psycho-pathological and quality of life assessmentsAlso: sleep testsPatients and Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests | Other | Group A, Group B, Healthy volunteers |
| HormonotherapyAdjuvant hormone therapy | Drug | Group A |
Primary outcome
The memory components and memory loss mechanisms by questionnaires
Time frame: 6 months after the end of radiotherapy
3 secondary outcomes
The effect of sleep quality on the recovery of intentions in prospective memory by questionnaires
Time frame: 6 months after the end of radiotherapy
The impact of adjuvant hormone therapy on the functioning of prospective memory by questionnaires
Time frame: 6 months after the end of radiotherapy
The influence of anxio-depressive factors and fatigue on prospective memory by questionnaires
Time frame: 6 months after the end of radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Derived from this study: PubMed 41309988Elia C, Perrier J, Duivon M, Rehel S, Gernier F, Fernette M, Doidy F, Clochon P, Grellard JM, Christy F, Segura-Djezzar C, Geffrelot J, Emile G, Allouache D, Viader F, Levy C, Joly F, Eustache F, Giffard B. Links between nocturnal hypoxia and cognitive function in breast cancer. Sci Rep. 2025 Nov 27;15(1):42405. doi: 10.1038/s41598-025-26591-z.
- Derived from this study: PubMed 30176833Duivon M, Perrier J, Joly F, Licaj I, Grellard JM, Clarisse B, Levy C, Fleury P, Madeleine S, Lefevre N, Rauchs G, Lecouvey G, Fraisse F, Viader F, Eustache F, Desgranges B, Giffard B. Impact of breast cancer on prospective memory functioning assessed by virtual reality and influence of sleep quality and hormonal therapy: PROSOM-K study. BMC Cancer. 2018 Sep 3;18(1):866. doi: 10.1186/s12885-018-4762-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological, psycho-pathological and quality of life assessments and Hormonotherapy in people with Breast Cancer and Memory Disorders, run by Centre Francois Baclesse at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The memory components and memory loss mechanisms by questionnaires (time frame: 6 months after the end of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03420105, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020.