Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy

• Status: Not yet recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborators: Allergan; Varian Medical Systems

Criteria

Inclusion Criteria:

1. 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

2. Completed a course of fractionated partial brain irradiation or whole brain irradiation of at least 30 (Gray) Gy more than 6 months prior to enrollment

3. Age ≥ 18 years at the time of entry into the study

4. Karnofsky performance score (KPS) ≥ 70 or Eastern Cooperative Oncology Group (ECOG) grade ≤ 2.

5. No imaging evidence of disease progression within 4 months of enrollment

6. Life expectancy > 6 months

7. Access to a smartphone, tablet, or computer with capability to utilize the mobile symptom-tracking application

Exclusion Criteria:

1. Active psychiatric illness

2. Clinically significant renal disease or insufficiency at the time of screening

3. History of severe liver disease or laboratory values for liver function tests > 2.5 times the upper limit of normal at screening

4. 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.

5. Allergy to Namzaric or any of the components of Namzaric.

6. Pregnancy