Memantine +/- Raloxifene for Cognitive Preservation After Radiation Therapy to the Brain

Официальное название

Memory RT: Memantine +/- Raloxifene for Cognitive Preservation After Radiation Therapy to the Brain

Обзор

The study investigators are testing to see if patients receiving radiation treatment for brain cancer along with raloxifene plus memantidine take longer to develop memory issues. The study will include anyone over the age of 18 who will be treated with radiation for brain cancer.

Подробное описание

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?

Вмешательства

• Препарат Memantine
  The goal dose for Immediate Release Memantine is 10 mg oral twice daily. The goal-dose for Extended-Release Memantine is 21 mg daily.
• Препарат Raloxifene
  Raloxifene will be administered at 120mg orally every day

Первичные конечные точки

• Hippocampal volume changes [Срок оценки: Baseline to 48 weeks]

Вторичные конечные точки (12)

• Eastern Cooperative Oncology Group Performance Status score [Срок оценки: Baseline to study termination visit (approximately 48 weeks)]
• Hopkins Verbal Learning Test Revised (HLVT-R) Score [Срок оценки: Week 0 to study termination visit (approximately 48 weeks)]
• Trail Making Test -A (TMT-A) Score [Срок оценки: Week 0 to study termination visit (approximately 48 weeks)]
• Trail Making Test -B (TMT-B) Score [Срок оценки: Week 0 to study termination visit (approximately 48 weeks)]
• Controlled Oral Word Association (COWA) Test Score [Срок оценки: Week 0 to study termination visit (approximately 48 weeks)]
• European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Brain (BN)tumor-20 [Срок оценки: Week 0 to study termination visit (approximately 48 weeks)]
• MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) [Срок оценки: Week 0 to study termination visit (approximately 48 weeks)]
• Functional Assessment of Cancer Therapy - Brain (FACT-Br) [Срок оценки: Week 0 to study termination visit (approximately 48 weeks)]
• Medical Outcomes Study - Cognitive Function (MOS-CF) [Срок оценки: Week 0 to study termination visit (approximately 48 weeks)]
• Patient Reported Outcomes Measurement Information System - Cognitive Function (PROMIS-CF) [Срок оценки: Week 0 to study termination visit (approximately 48 weeks)]
• Hopkins Verbal Learning Test Revised HLVT-R DR [Срок оценки: Week 0 to study termination visit (approximately 48 weeks)]
• Hopkins Verbal Learning Test Revised HLVT-R RECOG [Срок оценки: Week 0 to study termination visit (approximately 48 weeks)]

Критерии участия

Критерии включения

• Age ≥ 18 years.
• Ability to provide informed written consent in either English or Spanish.
• 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.
• 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.
• Patients must have a creatinine clearance ≥ 50 mL/min (using Cockcroft-Gault Equation).
• Patients must not have hepatic impairment greater than Child-Pugh Score "Class A".

Критерии исключения

• History of prior radiotherapy to the brain.
• Life expectancy of < 6 months.
• Radiation Therapy planned is ≤ 5 fractions (e.g.stereotactic radiosurgery (SRS)or Steriotactic radiotherapy (SRT), or 5-fraction whole brain).
• Contraindications to taking memantine and/or raloxifene based on package inserts and the clinical judgement of the treating physician .
• The subject is unable to undergo magnetic resonance imaging (MRI) scan (e.g., has an MRI incompatible pacemaker).
• 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.
• Known allergy to either of the medications (Memantine or Raloxifene) used in this study or their excipients.
• Cognitive failure as assessed by Mini Mental State Exam (MMSE) score <17

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Mays Cancer Center, UT Health San Antonio — San Antonio

Идентификаторы

NCT: NCT07470606 · CTMS# 25-0146

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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