Memory RT: Memantine +/- Raloxifene for Cognitive Preservation After Radiation Therapy to the Brain
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Hippocampal volume changes
研究概览
简要总结
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.
详细描述
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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".
排除标准
- •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
研究组 & 干预措施
Group A: Standard of Care
Patients will start Memantine as SOC around the time of radiation. Memantine may be continued as SOC as prescribed by the treating physician after the 24 weeks.
干预措施: Memantine (Drug)
Group B: Standard of Care plus raloxifene
Patients will start Memantine as SOC around the time of radiation. Memantine may be continued as SOC as prescribed by the treating physician after the 24 weeks.
If randomized to group B patients will be recommended to start the assigned Raloxifene at least one week before their anticipated RT treatment start date.
干预措施: Memantine (Drug)
Group B: Standard of Care plus raloxifene
Patients will start Memantine as SOC around the time of radiation. Memantine may be continued as SOC as prescribed by the treating physician after the 24 weeks.
If randomized to group B patients will be recommended to start the assigned Raloxifene at least one week before their anticipated RT treatment start date.
干预措施: Raloxifene (Drug)
结局指标
主要结局
Hippocampal volume changes
时间窗: Baseline to 48 weeks
MRIs will be used to capture any changes in hippocampal volume
次要结局
- Eastern Cooperative Oncology Group Performance Status score(Baseline to study termination visit (approximately 48 weeks))
- Patient Reported Outcomes Measurement Information System - Cognitive Function (PROMIS-CF)(Week 0 to study termination visit (approximately 48 weeks))
- Hopkins Verbal Learning Test Revised (HLVT-R) Score(Week 0 to study termination visit (approximately 48 weeks))
- Trail Making Test -A (TMT-A) Score(Week 0 to study termination visit (approximately 48 weeks))
- Trail Making Test -B (TMT-B) Score(Week 0 to study termination visit (approximately 48 weeks))
- Medical Outcomes Study - Cognitive Function (MOS-CF)(Week 0 to study termination visit (approximately 48 weeks))
- Controlled Oral Word Association (COWA) Test Score(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(Week 0 to study termination visit (approximately 48 weeks))
- MD Anderson Symptom Inventory Brain Tumor (MDASI-BT)(Week 0 to study termination visit (approximately 48 weeks))
- Functional Assessment of Cancer Therapy - Brain (FACT-Br)(Week 0 to study termination visit (approximately 48 weeks))
- Hopkins Verbal Learning Test Revised HLVT-R DR(Week 0 to study termination visit (approximately 48 weeks))
- Hopkins Verbal Learning Test Revised HLVT-R RECOG(Week 0 to study termination visit (approximately 48 weeks))
研究者
Andrew Brenner
Professor
The University of Texas Health Science Center at San Antonio