Detailed Description
As cognitive decline is a common side effect after external beam radiation therapy to the brain, estrogen receptor beta (ERβ) modulation presents an unexploited target for mitigating this adverse effect as well.
The investigators seek to address two scientific questions to improve quality of life in patients and improve cancer outcomes: 1) can estrogen modulation further augment neuroprotection achieved by memantine after radiation therapy to the brain? and 2) can estrogen modulation lead to measurable tumor control improvement and molecular changes in CNS malignancies?
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
1. Age ≥ 18 years.
2. Ability to provide informed written consent in either English or Spanish.
3. All individuals of childbearing potential must have a negative serum pregnancy test and male and female subjects must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an Intrauterine device (IUD)) with their partner from entry into the study through 24 weeks after the last dose of Raloxifene.
4. Patients undergoing radiation therapy to the brain as a part of solid tumor cancer therapy, using intensity modulated radiation therapy (IMRT) or whole brain radiation therapy (WBRT).Willingness to adhere to planned study drug regimen, including obtaining medication from an outside pharmacy via prescription.
5. Patients must have a creatinine clearance ≥ 50 mL/min (using Cockcroft-Gault Equation).
6. Patients must not have hepatic impairment greater than Child-Pugh Score "Class A".
Exclusion Criteria:
1. History of prior radiotherapy to the brain.
2. Life expectancy of \< 6 months.
3. Radiation Therapy planned is ≤ 5 fractions (e.g.stereotactic radiosurgery (SRS)or Steriotactic radiotherapy (SRT), or 5-fraction whole brain).
4. Contraindications to taking memantine and/or raloxifene based on package inserts and the clinical judgement of the treating physician .
5. The subject is unable to undergo magnetic resonance imaging (MRI) scan (e.g., has an MRI incompatible pacemaker).
6. Conditions or situations which, in the opinion of the investigator, imply the patient will be unable or not suitable to complete trial requirements or at excessive risk from trial participation.
7. Known allergy to either of the medications (Memantine or Raloxifene) used in this study or their excipients.
8. Cognitive failure as assessed by Mini Mental State Exam (MMSE) score \<17