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

ConditionBrain Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 .

Trial design

Design model

Parallel

Treatments tested in this trial

  • Memantine

    Drug

    The goal dose for Immediate Release Memantine is 10 mg oral twice daily. The goal-dose for Extended-Release Memantine is 21 mg daily.

  • Raloxifene

    Drug

    Raloxifene will be administered at 120mg orally every day

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: Group A: Standard of CareActive comparator 1 intervention
Group B: Group B: Standard of Care plus raloxifeneExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Hippocampal volume changes

MRIs will be used to capture any changes in hippocampal volume

Time frame
Baseline to 48 weeks

Secondary outcomes

1

Eastern Cooperative Oncology Group Performance Status score

A 0-5 scale to assess a cancer patient's functional ability showing how their daily life is impacted by the disease. A score of 0 means fully active, while a higher score indicates increasing disability with 5 indicating death.

Time frame
Baseline to study termination visit (approximately 48 weeks)
2

Hopkins Verbal Learning Test Revised (HLVT-R) Score

HVLT-R scoring involves summing words recalled in learning trials for Total Recall, calculating Percentage Retention (Delayed Recall / Higher of Trials 2/3), and determining the Recognition Discrimination Index (True Positives - False Positives). These raw scores are then converted to age-adjusted T-scores, which are compared to normative data (16-92 years old) to assess verbal learning and memory in brain-disordered populations, with higher scores generally indicating better performance.

Time frame
Week 0 to study termination visit (approximately 48 weeks)
3

Trail Making Test -A (TMT-A) Score

A neuropsychological number test measuring psychomotor speed and visual attention by connecting numbers (1-25) in sequence. Higher scores (more time) indicate greater impairment, with averages around 29 seconds, while scores over 30-40 seconds often suggest potential cognitive issues, though norms vary by age and education.

Time frame
Week 0 to study termination visit (approximately 48 weeks)
4

Trail Making Test -B (TMT-B) Score

A neuropsychological number and letter test measuring psychomotor speed and visual attention by connecting numbers (1-25) in sequence. Higher scores (more time) indicate greater impairment, with averages around 75 seconds, while scores over 273 second often suggest potential cognitive issues, though norms vary by age and education.

Time frame
Week 0 to study termination visit (approximately 48 weeks)

Other outcomes

Sponsors and contacts

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