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

StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 19, 2024 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Interventions: Memantine Oral Tablet (Drug) to Hippocampal avoidance whole-brain radiotherapy (HA-WBRT) (Radiation), Memantine Oral Tablet (Drug), Pioglitazone 15mg (Drug)v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
(from sponsor)
Radiation Disease, Cognitive Impairment, Drug Effect
Related terms Abnormalities, Radiation-Induced, Cognitive Dysfunction
Enrollment 67 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov