Clinical trial · Interventional
CHEmotherapy and Cognitive Deterioration in Patients With Operable Breast Cancer: Impact of Cognitive Rehabilitation (CHEMOFOG)
CHEMioterapia e Deterioramento cOgnitivo Nelle Pazienti aFfette da Carcinoma Mammario
NCT06435559CI-TRIAL-00077577CHEMOFOGunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neuropsychological evaluations | Other | — | UNRESOLVED |
| Neurotablet® and Neuropsychological evaluations | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A-experimental group
- description
- Patient enrolled in a cognitive rehabilitation program using Neurotablet® and paper and pencil exercises
- interventionNames
- Other: Neurotablet® and Neuropsychological evaluations
- type
- OTHER
- label
- B-control group
- description
- Patient NOT enrolled in a cognitive rehabilitation program using Neurotablet® and paper and pencil exercises.
- interventionNames
- Other: Neuropsychological evaluations
Primary outcomes (1)
- measure
- The effectiveness of a 10-week cognitive rehabilitation program
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Signature of informed consent * Diagnosis of operable/operated breast cancer * Patients candidate to be treated with Neo/adjuvant chemotherapy Exclusion Criteria: * 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
References
Publications (27)
- BACKGROUNDLauby-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. PMID 26039523
- BACKGROUNDRodriguez 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. PMID 33265966
- BACKGROUNDWefel 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. PMID 20564075
- BACKGROUNDErcoli 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. PMID 25759235
- BACKGROUNDHurria A, Somlo G, Ahles T. Renaming "chemobrain". Cancer Invest. 2007 Sep;25(6):373-7. doi: 10.1080/07357900701506672. PMID 17882646
- BACKGROUNDArgyriou 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. PMID 20832978
- BACKGROUNDSioka 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.