Study of Memantine to Prevent and Treat Nerve Damage Caused by Paclitaxel in Women with Early Stage Breast Cancer

What this Trial Is About

Cancer is a major cause of illness and death worldwide, and chemotherapy drugs, while effective against cancer cells, often cause side effects. One serious side effect is chemotherapy-induced peripheral neuropathy CIPN, which can be severe and affect daily activities and quality of life. This trial focuses on paclitaxel-induced peripheral neuropathy PIPN, which includes symptoms like numbness and pain that start in fingers and toes and may progress upwards. Memantine, a drug used for Alzheimers disease, has shown potential to reduce chronic pain and neuroinflammation and is being studied here for its effects on PIPN. The study is a phase 2, randomized, triple-blind trial comparing memantine hydrochloride 20 mg once daily with a placebo, alongside weekly paclitaxel chemotherapy 80 mgm2 for 12 weeks in female breast cancer patients. Forty patients will receive memantine plus paclitaxel, and another forty will receive placebo plus paclitaxel. The aim is to evaluate memantines ability to prevent or reduce paclitaxel-induced peripheral neuropathy. Participants will be monitored weekly for 12 weeks to assess the incidence and severity of neuropathy and pain. Quality of life and depressive symptoms will be evaluated at the start, 6 weeks, and 12 weeks. Blood samples will be collected to measure nerve growth factor levels at baseline and study end. Safety monitoring includes observing adverse reactions and patient well-being throughout the study period, which lasts 12 weeks. The trial is sponsored by Ain Shams University and excludes patients with certain medical conditions or medications.

"The Effect of Memantine on the Prevention and Amelioration of Paclitaxel-induced Toxicity in Breast Cancer Patients"