Lung Cancer Clinical Trial
Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy
The primary objectives of this randomized, placebo-controlled, double-blind study are to 1) assess whether or not Namzaric® improves cognitive function in cancer survivors who received prior brain irradiation as part of their standard of care therapy and 2) assess the feasibility of using a digital symptom tracking application focused on Health Related Quality of Life (HRQoL) and cognition in cancer survivors who received brain irradiation. Exploratory objectives include assessing longitudinally the effect of Namzaric® on Patient Reported Outcomes (PROs) as reported in the clinic, including measures of health-related quality of life, cognition, and financial toxicity and evaluating the safety and tolerability of administering Namzaric® to cancer survivors who have received prior irradiation.
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 and Edmonton Symptom Assessment Scale) during treatment (weeks 9 and 14). There will be no patient follow-up after completing or discontinuing the study.
Cancer survivors who received cranial irradiation including, but not limited to, primary brain tumor, brain metastases, lung cancer receiving prophylactic brain irradiation, long-term survivors of pediatric cancers
Completed a course of fractionated partial brain irradiation, or whole brain irradiation, or stereotactic radiosurgery (for any modality at least a total cumulative dose of 20 Gy) more than 6 months prior to enrollment
Age ≥ 18 years at the time of entry into the study
Karnofsky performance score (KPS) ≥ 70 or Eastern Cooperative Oncology Group (ECOG) grade ≤ 2.
No imaging evidence of disease progression within 4 months of enrollment
Life expectancy > 6 months
Access to a smartphone, tablet, or computer with capability to utilize the mobile symptom-tracking application
Signed informed consent approved by the Institutional Review Board
Subject must be fluent in English
Active psychiatric illness
Clinically significant renal disease or insufficiency at the time of screening
History of severe liver disease or laboratory values for liver function tests > 2.5 times the upper limit of normal at screening
Use of cognition-enhancing medications at the time of screening. If patients have used cognition-enhancing medications in the past, a wash-out period can be considered for screening of 8 weeks at the discretion of the PI.
Allergy to Namzaric or any of the components of Namzaric.
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There is 1 Location for this study
Durham North Carolina, 27710, United States
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