Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Brain Metastases, Adult
  • Lung Cancer
  • Primary Brain Tumor
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Patients who may participate in the study are cancer survivors who received cranial irradiation for conditions including, but not limited to: primary brain tumors, brain metastases, patients with lung cancer receiving prophylactic brain irradiation, and long-term survivors of pediatric cancers. Up t...

Patients who may participate in the study are cancer survivors who received cranial irradiation for conditions including, but not limited to: primary brain tumors, brain metastases, patients with lung cancer receiving prophylactic brain irradiation, and long-term survivors of pediatric cancers. Up to 102 patients will be randomized 1:1 so half the patients receive Namzaric® and half receive placebo. Patients on both arms will be taking Namzaric® or placebo for 17 weeks, including dose-escalation and tapering. Patients will use a symptom monitoring app, Noona® Healthcare Mobile PRO Application, to identify real-time select HRQoL and cognitive symptoms during Namzaric® vs placebo therapy. Patients will be instructed to log symptoms as often as relevant using their own personal devices, as well as be prompted to fill out the Patient-Reported Outcomes Measurement Information System Global Health Screen (PROMIS Global Health-10) during treatment (weeks 9 and 14). There will be no patient follow-up after completing or discontinuing the study.

Tracking Information

NCT #
NCT04567251
Collaborators
  • Allergan
  • Varian Medical Systems
Investigators
Principal Investigator: Katherine Peters, MD, PhD Duke University