Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Bacopa Monnieri Capsules for mitigating cognitive dysfunction in breast cancer patients: Bacopa Monnieri 225mg Capsules will be given twice daily for a duration of three months (12 week
Sponsors
Kasturba Medical College Manipal
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women aged 18 years and above 2. Confirmed diagnosis of non-metastatic breast cancer, completed chemotherapy and on maintenance therapy or follow-up OR Confirmed diagnosis of metastatic breast cancer (excluding brain metastases) and receiving hormonal therapy and/or targeted therapy 3. Willing and able to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Prior use of Bacopa monnieri or other cognitive-enhancing agents in the last one year 2. Patients with a history of neurological disorders known to affect cognitive function, including but not limited to stroke, epilepsy, traumatic brain injury, dementia, multiple sclerosis, or other central nervous system disorders 3. Known psychiatric conditions who lack insight 4. Metastasis to Brain 5. Presence of any significant structural abnormality of the brain (e.g., congenital malformations, prior stroke, space-occupying lesions, hydrocephalus), as identified from past medical history or imaging, which could independently affect cognition 6. History of allergy to any medications, including alternate systems of medications 7. Abnormalities in the liver function tests (SGOT/SGPT 3 times the upper limit of normal) 8. Abnormal renal function test (eGFR less than 60 9. Women of reproductive age who are pregnant / lactating / not willing for adequate contraception 10. Inability to follow the protocol or expressed inability to complete all follow-ups 11. Physical limitations, including vision and hearing impairment 12. Other medical/surgical conditions, in the opinion of the investigator, may cause harm to the participant or influence the quality of data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive function score at 12 weeks measured by FACT-Cog Version 3Timepoint: Baseline, Week 12 (3 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| scores of visuospatial/executive function, naming, attention, language, abstraction, delayed recall, and orientation using MoCa Timepoint: Baseline, Week 12 (3 months);Quality of life measured by EORTC QLQ-C30 Timepoint: Baseline, Week 12 (3 months);Confounders measured by GAD-7, PSS4, PHQ-9Timepoint: Baseline, Week 12 (3 months) | — |
Countries
India
Contacts
Public ContactDr Jeffrey Pradeep Raj
Kasturba Medical College Manipal
Outcome results
None listed