Using Memantine to Reduce Nerve Damage from Paclitaxel in Breast Cancer Patients
"The Effect of Memantine on the Prevention and Amelioration of Paclitaxel-induced Toxicity in Breast Cancer Patients"
This study is testing if the drug Memantine can help breast cancer patients who are getting chemotherapy with Paclitaxel by reducing nerve damage and improving their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ain Shams University Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06679387 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Memantine in preventing and alleviating peripheral neuropathy caused by the chemotherapy drug Paclitaxel in patients with early-stage breast cancer. The study will involve adult patients who are scheduled to receive weekly adjuvant or neo-adjuvant Paclitaxel treatment. Participants will be randomly assigned to receive either Memantine or a placebo, and their symptoms of neuropathy will be monitored throughout the treatment period. The goal is to determine if Memantine can improve the quality of life for patients by reducing the severity of chemotherapy-induced nerve damage.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with non-metastatic breast cancer who are about to start Paclitaxel treatment.
Not a fit: Patients with pre-existing neuropathic conditions, diabetes, or those on medications that induce peripheral neuropathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for breast cancer patients undergoing chemotherapy by reducing painful nerve damage.
How similar studies have performed: While some studies have explored treatments for chemotherapy-induced peripheral neuropathy, the use of Memantine for this specific purpose is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (\>18 years old). * Patients with confirmed diagnosis of non-metastatic breast cancer planned to receive weekly adjuvant/neo-adjuvant paclitaxel. * Patients with Eastern Cooperative Oncology Group (ECOG) performance (Oken et al., 1982) status of 0-2. Exclusion Criteria: * Patients with pre-existing neuropathic conditions. * Patients with diabetes mellitus. * Patients with a history of seizure disorder. * Patients with renal impairment (creatinine clearance less than 60 ml/min), or hepatic impairment (defined as ALT an AST \> 3 times upper limits of normal) * Patients with inadequate bone marrow functions (defined as absolute neutrophilic count less than 1,500/mm3 or platelets count less than 100,000/mm3). * Concomitant use of vitamin B1, B6, B9, or B12. * Patients receiving medications that possibly induce peripheral neuropathy including amiodarone, colchicine, metronidazole, antimycobacterials, and nucleoside reverse transcriptase inhibitors, and phenytoin (Jones et al., 2020). * Patients receiving gabapentinoids, antidepressants, or opioids. * Pregnancy or lactation. * History of hypersensitivity to memantine.
Where this trial is running
Cairo
- Ain shams University Hospitals — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Mahmoud M Gharib, Assistant lecturer
- Email: dr.mahmoudgharib.mg@gmail.com
- Phone: 02 01286584470
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.