Status:
NOT_YET_RECRUITING
Early Application of Memantine and Pioglitazone to Protect Cognitive Function After Radiotherapy
Lead Sponsor:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Collaborating Sponsors:
Guangdong Provincial People's Hospital
Fujian Medical University Union Hospital
Conditions:
Radiation Disease
Cognitive Impairment
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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....
Eligibility Criteria
Inclusion
- Recursive Partitioning Analysis (RPA), Class I \~ Class II
- Karnofsky Performance Status of ≥70
- The primary tumor must be pathologically confirmed. For newly diagnosed brain metastases, the number of metastases is not limited, but the brain metastases could not have been within 5 mm of hippocampus. Additionally, there must be no hard or soft meningeal metastases.
- No history of whole-brain radiation therapy; patients who are eligible for surgical resection of brain metastases prior to radiation therapy are allowed.
- Bone marrow function: White blood cell count ≥ 4 × 10⁹/L, hemoglobin ≥ 90 g/L, and platelet count ≥ 100 × 10⁹/L.
- Adequate hepatic function: Total bilirubin ≤ 1.5 × ULN (Upper Limit of Normal); ALT (alanine aminotransferase), AST (aspartate aminotransferase) ≤ 2.5 × ULN; ALP (alkaline phosphatase) ≤ 2.5 × ULN and total bilirubin ≤ ULN.
- Adequate renal function: creatinine clearance rate ≥ 30 ml/min.
- Patients or their legal guardians voluntarily participate and sign the informed consent form.
Exclusion
- Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, including placement of external ventricular drain or ventriculoperitoneal shunt.
- Planned cytotoxic chemotherapy during the WBRT.
- Pregnant or lactating women (Women of childbearing age must undergo a pregnancy test; effective contraception must be enforced during the treatment period).
- Previous cranial radiation therapy (Except for patients with head and neck cancer where the disease site is outside the cranial radiation field).
- Severe or active symptomatic cardiopulmonary diseases; clinically significant psychiatric disorders; Personality or psychiatric disease; Severe hepatic disease defined as a diagnosis of Child-Pugh class B or C hepatic disease;
- Intolerant to or allergic to Memantine or pioglitazone.
- Difficulty swallowing, chronic diarrhea, or bowel obstruction.
- NYHA class III or IV heart failure or symptomatic peripheral edema (grade 2 or higher); those treated with insulin or oral hypoglycemic agents for steroid-induced hyperglycemia, or those currently using other NMDA antagonists.
Key Trial Info
Start Date :
September 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT06594172
Start Date
September 10 2024
End Date
June 30 2027
Last Update
September 19 2024
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