Breast CancerCHEMOFOGNCT06435559
CHEmotherapy and Cognitive Deterioration in Patients With Operable Breast Cancer: Impact of Cognitive Rehabilitation (CHEMOFOG)
A study testing Neurotablet® and Neuropsychological evaluations and Neuropsychological evaluations in people with Breast Cancer, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
Trial summary
An interventional, non-pharmacological, monocentric study evaluating the effectiveness of cognitive rehabilitation in counteracting chemotherapy-induced cognitive impairment (CRCI) in women with operable breast cancer treated with neo-adjuvant therapy and/ or adjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Neurotablet® and Neuropsychological evaluations and Neuropsychological evaluations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Jun 2026
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signature of informed consent
- Diagnosis of operable/operated breast cancer
- Patients candidate to be treated with Neo/adjuvant chemotherapy
Who cannot join
- Previous chemotherapy treatments
- Patients with Metastatic breast cancer
- Patients affected by pathologies of the brain, head trauma, and intellectual disabilities
- Patients affected by previous or current neurological and/or psychiatric disorders
- Patients currently treated with psychopharmacological drug
Trial locations and contacts
No sites are listed yet.
About this study
Official title: CHEMioterapia e Deterioramento cOgnitivo Nelle Pazienti aFfette da Carcinoma Mammario
An interventional, non-pharmacological, monocentric study evaluating the effectiveness of cognitive rehabilitation in counteracting chemotherapy-induced cognitive impairment (CRCI) in women with operable breast cancer treated with neo-adjuvant therapy and/ or adjuvant therapy.
Read the detailed description
This interventional, non-pharmacological, monocentric study examines the effectiveness of cognitive rehabilitation in counteracting CRCI in women with operable breast cancer treated with neo-adjuvant therapy and/ or adjuvant therapy.
A total of 128 patients will be randomized 1:1 into two groups:
- Experimental group, which will participate in a cognitive rehabilitation program using Neurotablet® and paper and pencil exercises. To evaluate the efficacy of the cognitive rehabilitation program, neurocognitive evaluations will be performed.
- Control group, which will only carry out neuropsychological assessments.
Neuropsychological evaluations will be conducted before the start of chemotherapy (T0), 6 months (T1) and 12 months (T2) after the start of chemotherapy. Neuropsychological evaluations will include tests to analyze the main cognitive domains of memory, attention, executive functions and learning.
- Conditions
- Breast Cancer
- Being tested
- Neurotablet® and Neuropsychological evaluations, Neuropsychological evaluations
- Keywords
- Chemotherapy-induced cognitive impairment, Neuropsychological assessments, Breast cancer, Adjuvant chemotherapy, Neo-adjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms, Chemotherapy-Related Cognitive Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurotablet® and Neuropsychological evaluationsOther
The experimental group will carry out cognitive rehabilitation using the Neurotablet device. The cognitive rehabilitation will be performed for 10 consecutive weeks, once a week for 1 hour. Neuropsychological evaluations will be conducted before the start of chemotherapy (T0), 6 months (T1) and 12 months (T2) after the start of chemotherapy. Neuropsychological evaluations will include tests to analyze the main cognitive domains of memory, attention, executive functions and learning.
Neuropsychological evaluationsOther
Neuropsychological evaluations will be conducted before the start of chemotherapy (T0), 6 months (T1) and 12 months (T2) after the start of chemotherapy. Neuropsychological evaluations will include tests to analyze the main cognitive domains of memory, attention, executive functions and learning.
| Study group | Role | What they receive |
|---|---|---|
| A-experimental group | Experimental | Patient enrolled in a cognitive rehabilitation program using Neurotablet® and paper and pencil exercises Receives: Other: Neurotablet® and Neuropsychological evaluations |
| B-control group | Other | Patient NOT enrolled in a cognitive rehabilitation program using Neurotablet® and paper and pencil exercises. Receives: Other: Neuropsychological evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of a 10-week cognitive rehabilitation program
Test the effectiveness of a 10-week cognitive rehabilitation program in limiting or preventing chemotherapy-induced cognitive impairment. To test the efficacy of this cognitive rehabilitation program, neurocognitive evaluations will be performed.
Measured: Neurocognitive evaluations will be performed at T0 (before chemotherapy program start), T1 (after 6 months from chemotherapy started), and T2 (after 12 months from chemotherapy started)
Secondary outcomes (1)
Analysis of cognitive function trends in the control group
Analysis of cognitive function trends though neurocognitive evaluations
Measured: Neurocognitive evaluations will be performed at T0 (before chemotherapy program start), T1 (after 6 months from chemotherapy started), and T2 (after 12 months from chemotherapy started)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ornella Garrone, MD, Principal investigator, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-SC Oncologia Medica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435559
- Sponsor's protocol ID
- CHEMOFOG
- Acronym
- CHEMOFOG
- Status last verified
- May 2024
- First submitted
- 19 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lauby-Secretan B, Scoccianti C, Loomis D, Benbrahim-Tallaa L, Bouvard V, Bianchini F, Straif K; International Agency for Research on Cancer Handbook Working Group. Breast-cancer screening--viewpoint of the IARC Working Group. N Engl J Med. 2015 Jun 11;372(24):2353-8. doi: 10.1056/NEJMsr1504363. Epub 2015 Jun 3. No abstract available.
PubMed 26039523Rodriguez Martin B, Fernandez Rodriguez EJ, Rihuete Galve MI, Cruz Hernandez JJ. Study of Chemotherapy-Induced Cognitive Impairment in Women with Breast Cancer. Int J Environ Res Public Health. 2020 Nov 30;17(23):8896. doi: 10.3390/ijerph17238896.
PubMed 33265966Wefel JS, Saleeba AK, Buzdar AU, Meyers CA. Acute and late onset cognitive dysfunction associated with chemotherapy in women with breast cancer. Cancer. 2010 Jul 15;116(14):3348-56. doi: 10.1002/cncr.25098.
PubMed 20564075Ercoli LM, Petersen L, Hunter AM, Castellon SA, Kwan L, Kahn-Mills BA, Embree LM, Cernin PA, Leuchter AF, Ganz PA. Cognitive rehabilitation group intervention for breast cancer survivors: results of a randomized clinical trial. Psychooncology. 2015 Nov;24(11):1360-7. doi: 10.1002/pon.3769. Epub 2015 Mar 10.
PubMed 25759235Hurria A, Somlo G, Ahles T. Renaming "chemobrain". Cancer Invest. 2007 Sep;25(6):373-7. doi: 10.1080/07357900701506672.
PubMed 17882646Argyriou AA, Assimakopoulos K, Iconomou G, Giannakopoulou F, Kalofonos HP. Either called "chemobrain" or "chemofog," the long-term chemotherapy-induced cognitive decline in cancer survivors is real. J Pain Symptom Manage. 2011 Jan;41(1):126-39. doi: 10.1016/j.jpainsymman.2010.04.021. Epub 2010 Sep 15.
PubMed 20832978Sioka C, Kyritsis AP. Central and peripheral nervous system toxicity of common chemotherapeutic agents. Cancer Chemother Pharmacol. 2009 Apr;63(5):761-7. doi: 10.1007/s00280-008-0876-6. Epub 2008 Nov 25.
PubMed 19034447Vezmar S, Schusseler P, Becker A, Bode U, Jaehde U. Methotrexate-associated alterations of the folate and methyl-transfer pathway in the CSF of ALL patients with and without symptoms of neurotoxicity. Pediatr Blood Cancer. 2009 Jan;52(1):26-32. doi: 10.1002/pbc.21827.
PubMed 19006245Vardy J, Dhillon H. The fog hasn't lifted on "chemobrain" yet: ongoing uncertainty regarding the effects of chemotherapy and breast cancer on cognition. Breast Cancer Res Treat. 2010 Aug;123(1):35-7. doi: 10.1007/s10549-009-0719-0. Epub 2010 Jan 6. No abstract available.
PubMed 20052534Iconomou G, Mega V, Koutras A, Iconomou AV, Kalofonos HP. Prospective assessment of emotional distress, cognitive function, and quality of life in patients with cancer treated with chemotherapy. Cancer. 2004 Jul 15;101(2):404-11. doi: 10.1002/cncr.20385.
PubMed 15241840Hurria A, Rosen C, Hudis C, Zuckerman E, Panageas KS, Lachs MS, Witmer M, van Gorp WG, Fornier M, D'Andrea G, Moasser M, Dang C, Van Poznak C, Hurria A, Holland J. Cognitive function of older patients receiving adjuvant chemotherapy for breast cancer: a pilot prospective longitudinal study. J Am Geriatr Soc. 2006 Jun;54(6):925-31. doi: 10.1111/j.1532-5415.2006.00732.x.
PubMed 16776787Von Ah D, Crouch A. Cognitive Rehabilitation for Cognitive Dysfunction after Cancer and Cancer Treatment: Implications for Nursing Practice. Semin Oncol Nurs. 2020 Feb;36(1):150977. doi: 10.1016/j.soncn.2019.150977. Epub 2020 Jan 17.
PubMed 31959511Bray VJ, Dhillon HM, Bell ML, Kabourakis M, Fiero MH, Yip D, Boyle F, Price MA, Vardy JL. Evaluation of a Web-Based Cognitive Rehabilitation Program in Cancer Survivors Reporting Cognitive Symptoms After Chemotherapy. J Clin Oncol. 2017 Jan 10;35(2):217-225. doi: 10.1200/JCO.2016.67.8201. Epub 2016 Oct 28.
PubMed 28056205Von Ah D. Cognitive changes associated with cancer and cancer treatment: state of the science. Clin J Oncol Nurs. 2015 Feb;19(1):47-56. doi: 10.1188/15.CJON.19-01AP.
PubMed 25689649Foderaro G, Isella V, Mazzone A, Biglia E, Di Gangi M, Pasotti F, Sansotera F, Grobberio M, Raimondi V, Mapelli C, Ferri F, Impagnatiello V, Ferrarese C, Appollonio IM. Brand new norms for a good old test: Northern Italy normative study of MiniMental State Examination. Neurol Sci. 2022 May;43(5):3053-3063. doi: 10.1007/s10072-021-05845-4. Epub 2022 Jan 6.
PubMed 34989910
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHEMioterapia e Deterioramento cOgnitivo Nelle Pazienti aFfette da Carcinoma Mammario
- ClinicalTrials.gov ID
- NCT06435559
- Acronym / sponsor ID
- CHEMOFOG / CHEMOFOG
- Conditions
- Breast Cancer
- Keywords
- Chemotherapy-induced cognitive impairment, Neuropsychological assessments, Breast cancer, Adjuvant chemotherapy, Neo-adjuvant chemotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 30 May 2024 (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.
An interventional, non-pharmacological, monocentric study evaluating the effectiveness of cognitive rehabilitation in counteracting chemotherapy-induced cognitive impairment (CRCI) in women with operable breast cancer treated with neo-adjuvant therapy and/ or adjuvant therapy.
Detailed description
This interventional, non-pharmacological, monocentric study examines the effectiveness of cognitive rehabilitation in counteracting CRCI in women with operable breast cancer treated with neo-adjuvant therapy and/ or adjuvant therapy.
A total of 128 patients will be randomized 1:1 into two groups:
- Experimental group, which will participate in a cognitive rehabilitation program using Neurotablet® and paper and pencil exercises. To evaluate the efficacy of the cognitive rehabilitation program, neurocognitive evaluations will be performed.
- Control group, which will only carry out neuropsychological assessments.
Neuropsychological evaluations will be conducted before the start of chemotherapy (T0), 6 months (T1) and 12 months (T2) after the start of chemotherapy. Neuropsychological evaluations will include tests to analyze the main cognitive domains of memory, attention, executive functions and learning.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-experimental group | Experimental | Other: Neurotablet® and Neuropsychological evaluationsPatient enrolled in a cognitive rehabilitation program using Neurotablet® and paper and pencil exercises |
| B-control group | Other | Other: Neuropsychological evaluationsPatient NOT enrolled in a cognitive rehabilitation program using Neurotablet® and paper and pencil exercises. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signature of informed consent
- Diagnosis of operable/operated breast cancer
- Patients candidate to be treated with Neo/adjuvant chemotherapy
Key exclusion criteria (5 listed)
- Previous chemotherapy treatments
- Patients with Metastatic breast cancer
- Patients affected by pathologies of the brain, head trauma, and intellectual disabilities
- Patients affected by previous or current neurological and/or psychiatric disorders
- Patients currently treated with psychopharmacological drug
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 |
|---|---|---|
| Neurotablet® and Neuropsychological evaluationsThe experimental group will carry out cognitive rehabilitation using the Neurotablet device. The cognitive rehabilitation will be performed for 10 consecutive weeks, once a week for 1 hour. Neuropsychological evaluations will be conducted before the start of chemotherapy (T0), 6 months (T1) and 12 months (T2) after the start of chemotherapy. Neuropsychological evaluations will include tests to analyze the main cognitive domains of memory, attention, executive functions and learning. | Other | A-experimental group |
| Neuropsychological evaluationsNeuropsychological evaluations will be conducted before the start of chemotherapy (T0), 6 months (T1) and 12 months (T2) after the start of chemotherapy. Neuropsychological evaluations will include tests to analyze the main cognitive domains of memory, attention, executive functions and learning. | Other | B-control group |
Primary outcome
The effectiveness of a 10-week cognitive rehabilitation program
Time frame: Neurocognitive evaluations will be performed at T0 (before chemotherapy program start), T1 (after 6 months from chemotherapy started), and T2 (after 12 months from chemotherapy started)
Test the effectiveness of a 10-week cognitive rehabilitation program in limiting or preventing chemotherapy-induced cognitive impairment. To test the efficacy of this cognitive rehabilitation program, neurocognitive evaluations will be performed.
1 secondary outcome
Analysis of cognitive function trends in the control group
Time frame: Neurocognitive evaluations will be performed at T0 (before chemotherapy program start), T1 (after 6 months from chemotherapy started), and T2 (after 12 months from chemotherapy started)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Background: PubMed 26039523Lauby-Secretan B, Scoccianti C, Loomis D, Benbrahim-Tallaa L, Bouvard V, Bianchini F, Straif K; International Agency for Research on Cancer Handbook Working Group. Breast-cancer screening--viewpoint of the IARC Working Group. N Engl J Med. 2015 Jun 11;372(24):2353-8. doi: 10.1056/NEJMsr1504363. Epub 2015 Jun 3. No abstract available.
- Background: PubMed 33265966Rodriguez Martin B, Fernandez Rodriguez EJ, Rihuete Galve MI, Cruz Hernandez JJ. Study of Chemotherapy-Induced Cognitive Impairment in Women with Breast Cancer. Int J Environ Res Public Health. 2020 Nov 30;17(23):8896. doi: 10.3390/ijerph17238896.
- Background: PubMed 20564075Wefel JS, Saleeba AK, Buzdar AU, Meyers CA. Acute and late onset cognitive dysfunction associated with chemotherapy in women with breast cancer. Cancer. 2010 Jul 15;116(14):3348-56. doi: 10.1002/cncr.25098.
- Background: PubMed 25759235Ercoli LM, Petersen L, Hunter AM, Castellon SA, Kwan L, Kahn-Mills BA, Embree LM, Cernin PA, Leuchter AF, Ganz PA. Cognitive rehabilitation group intervention for breast cancer survivors: results of a randomized clinical trial. Psychooncology. 2015 Nov;24(11):1360-7. doi: 10.1002/pon.3769. Epub 2015 Mar 10.
- Background: PubMed 17882646Hurria A, Somlo G, Ahles T. Renaming "chemobrain". Cancer Invest. 2007 Sep;25(6):373-7. doi: 10.1080/07357900701506672.
- Background: PubMed 20832978Argyriou AA, Assimakopoulos K, Iconomou G, Giannakopoulou F, Kalofonos HP. Either called "chemobrain" or "chemofog," the long-term chemotherapy-induced cognitive decline in cancer survivors is real. J Pain Symptom Manage. 2011 Jan;41(1):126-39. doi: 10.1016/j.jpainsymman.2010.04.021. Epub 2010 Sep 15.
- Background: PubMed 19034447Sioka C, Kyritsis AP. Central and peripheral nervous system toxicity of common chemotherapeutic agents. Cancer Chemother Pharmacol. 2009 Apr;63(5):761-7. doi: 10.1007/s00280-008-0876-6. Epub 2008 Nov 25.
- Background: PubMed 19006245Vezmar S, Schusseler P, Becker A, Bode U, Jaehde U. Methotrexate-associated alterations of the folate and methyl-transfer pathway in the CSF of ALL patients with and without symptoms of neurotoxicity. Pediatr Blood Cancer. 2009 Jan;52(1):26-32. doi: 10.1002/pbc.21827.
- Background: PubMed 20052534Vardy J, Dhillon H. The fog hasn't lifted on "chemobrain" yet: ongoing uncertainty regarding the effects of chemotherapy and breast cancer on cognition. Breast Cancer Res Treat. 2010 Aug;123(1):35-7. doi: 10.1007/s10549-009-0719-0. Epub 2010 Jan 6. No abstract available.
- Background: PubMed 15241840Iconomou G, Mega V, Koutras A, Iconomou AV, Kalofonos HP. Prospective assessment of emotional distress, cognitive function, and quality of life in patients with cancer treated with chemotherapy. Cancer. 2004 Jul 15;101(2):404-11. doi: 10.1002/cncr.20385.
- Background: PubMed 16776787Hurria A, Rosen C, Hudis C, Zuckerman E, Panageas KS, Lachs MS, Witmer M, van Gorp WG, Fornier M, D'Andrea G, Moasser M, Dang C, Van Poznak C, Hurria A, Holland J. Cognitive function of older patients receiving adjuvant chemotherapy for breast cancer: a pilot prospective longitudinal study. J Am Geriatr Soc. 2006 Jun;54(6):925-31. doi: 10.1111/j.1532-5415.2006.00732.x.
- Background: PubMed 31959511Von Ah D, Crouch A. Cognitive Rehabilitation for Cognitive Dysfunction after Cancer and Cancer Treatment: Implications for Nursing Practice. Semin Oncol Nurs. 2020 Feb;36(1):150977. doi: 10.1016/j.soncn.2019.150977. Epub 2020 Jan 17.
- Individual participant dataSharing planned: Undecided
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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.
Ornella Garrone, MD principal investigator
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-SC Oncologia Medica
Questions about this trial
What is this clinical trial studying?
A study testing Neurotablet® and Neuropsychological evaluations and Neuropsychological evaluations in people with Breast Cancer, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ornella Garrone, MD (+390255032660, ornella.garrone@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effectiveness of a 10-week cognitive rehabilitation program (time frame: Neurocognitive evaluations will be performed at T0 (before chemotherapy program start), T1 (after 6 months from chemotherapy started), and T2 (after 12 months from chemotherapy started)). 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 NCT06435559, which also lists 27 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 30 May 2024.