Early Application of Memantine and Pioglitazone to Protect Cognitive Function After Radiotherapy

This clinical trial aims to evaluate the efficacy of early intervention with Memantine and Pioglitazone in preventing Radiation-Induced Brain Injury (RIBI) in patients undergoing cranial radiotherapy. RIBI, a significant complication of radiation therapy for primary and metastatic brain tumors, as well as head and neck cancers, often presents with delayed and irreversible neurological damage, severely affecting patients' quality of life. Our previous studies have indicated that Memantine, an NMDAR antagonist, and Pioglitazone, a PPAR-γ agonist, play crucial roles in modulating the neuroprotective immune microenvironment by targeting key mechanisms of neuron-astrocyte fatty acid metabolism coupling. These findings suggest that early administration of these drugs could protect cognitive function and reduce neuroinflammation in patients post-radiation. This prospective phase II clinical trial will assess the combined efficacy of Memantine and Pioglitazone in improving cognitive outcomes and preventing RIBI without adversely impacting the anti-tumor efficacy of radiation therapy. The study will also explore the synergistic effects of these two FDA-approved drugs in early-stage RIBI prevention, providing a new therapeutic strategy for enhancing the quality of life in cancer patients receiving radiotherapy.

NCT Number	NCT06594172
Lead Sponsor	Affiliated Cancer Hospital & Institute of Guangzhou Medical University Collaborators: Guangdong Provincial People's Hospital, Fujian Medical University Union Hospital, Southern Medical University, China, The Affiliated Panyu Center Hospital of Guangzhou Medical University, The Central Hospital of Shaoyang City
Conditions	Radiation Disease, Cognitive Impairment, Drug Effect
Enrollment	67 participants
Start Date	2024-09-10
Primary Completion	2025-12-30 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2024-09-19