Lung Cancer Clinical Trial

Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy

Summary

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.

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Full 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 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.
Pregnancy

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

108

Study ID:

NCT04567251

Recruitment Status:

Suspended

Sponsor:

Duke University

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There is 1 Location for this study

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Duke University Medical Center
Durham North Carolina, 27710, United States

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Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

108

Study ID:

NCT04567251

Recruitment Status:

Suspended

Sponsor:


Duke University

How clear is this clinincal trial information?

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