Clinical trial · Observational
A Prospective Study on Effect of Systemic Adjuvant Therapy on Cognitive and Brain Function of Breast Cancer Patients
A Prospective Pilot Study to Evaluate the Effect of Systemic Adjuvant Therapy on the Cognitive and Brain Function of Breast Cancer Patients
NCT02078531CI-TRIAL-00047469unknownClinicalTrials.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)
The purpose of the study is to examine cognitive and brain function in stage I-III breast cancer patients who have undergone adjuvant systemic therapy (chemotherapy or chemotherapy plus anti-hormonal therapy) in comparison to a group of healthy controls. Our hypothesis is that systemic adjuvant therapy in the form of chemotherapy or chemotherapy and anti-hormonal therapy given to primary breast cancer patients can cause cognitive impairment. We hypothesize that the use of simultaneous PET/MRI will allow us to determine key regions in the brain that show metabolic, structural, and functional deficits in a semi-quantitative manner and reveal subtle changes that are often missed during neuropsychological tests due to the low sensitivity of neuropsychological batteries.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Chemotherapy and anti-hormonal therapy
- description
- 1. cognitive assessment using CANTAB 2. Imaging to assess the effect of systemic therapy on brain function. Subjects may participate in the first part of the study without undergoing the imaging assessment or may participate in both parts of the study.
- label
- chemotherapy only and healthy control group
- description
- 1. cognitive assessment using CANTAB 2. Imaging to assess the effect of systemic therapy on brain function. Subjects may participate in the first part of the study without undergoing the imaging assessment or may participate in both parts of the study.
Primary outcomes (1)
- measure
- Change the relationship between chemotherapy/anti-hormonal therapy and possible cognitive decline in patients undergoing such therapy
- timeFrame
- 1 year
- description
- We hope to gain a better understanding of the complex and currently poorly understood relationship between chemotherapy/anti-hormonal therapy and possible cognitive decline in patients undergoing such therapy. In current practice, a large number of patients with primary breast cancer are offered adjuvant chemotherapy after surgery, followed by hormonal therapy in patients whose tumours are hormone receptor-positive. The management of many adverse effects of chemotherapy, such as nausea, vomiting and febrile neutropenia has improved, and concern has shifted to more subtle and potentially chronic problems such as cognitive dysfunction, which may affect patients' quality of life.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed stage I-III breast carcinoma 2. \<65 years old 3. Female 4. Scheduled to receive chemotherapy containing doxorubicin/cyclophosphamide once every 3 weeks for 4 cycles and weekly paclitaxel for 12 cycles starting in either the adjuvant or neoadjuvant setting 5. May receive adjuvant endocrine therapy subsequently (endocrine therapy can be either tamoxifen or aromatase inhibitors) Inclusion Criteria for Healthy Controls Each subject must meet the following criteria to be enrolled in this study. 1. \<65 years old 2. Female Exclusion Criteria: 1. Previous exposure to chemotherapy/anti-hormonal therapy for any other malignancy 2. Concomitant second primary in-situ or invasive carcinoma or previous history of carcinoma/carcinoma-in-situ 3. Known disease or injury to the central nervous system (including neurodegenerative diseases, epilepsy), severe visual or auditory disorders 4. Motor weakness due to any cause which makes using a touchscreen computer difficult 5. Known background of depression, anxiety disorders or other neurobehavioural conditions 6. Previous history of cognitive impairment 7. Ongoing use of tranquilisers or anti-depressants 8. Previous neuropsychological testing 9. Current or previous history of alcohol or drug dependence Exclusion Criteria for Healthy Controls Subjects who meet any of the following criteria will be excluded from the study. 1. Previous exposure to chemotherapy/anti-hormonal therapy for any other malignancy 2. Concomitant second primary in-situ or invasive carcinoma or previous history of carcinoma/carcinoma-in-situ 3. Known disease or injury to the central nervous system (including neurodegenerative diseases, epilepsy), severe visual or auditory disorders 4. Motor weakness due to any cause which makes using a touchscreen computer difficult 5. Known background of depression, anxiety disorders or other neurobehavioural conditions 6. Previous history of cognitive impairment 7. Ongoing use of tranquilisers or anti-depressants 8. Previous neuropsychological testing 9. Current or previous history of alcohol or drug dependence
References
Publications (2)
- BACKGROUNDBhoo-Pathy N, Hartman M, Yip CH, Saxena N, Taib NA, Lim SE, Iau P, Adami HO, Bulgiba AM, Lee SC, Verkooijen HM. Ethnic differences in survival after breast cancer in South East Asia. PLoS One. 2012;7(2):e30995. doi: 10.1371/journal.pone.0030995. Epub 2012 Feb 21. PMID 22363531
- BACKGROUNDPolychemotherapy for early breast cancer: an overview of the randomised trials. Early Breast Cancer Trialists' Collaborative Group. Lancet. 1998 Sep 19;352(9132):930-42. PMID 9752815