QOL-39. A pilot phase 1b clinical trial proposal to study safety and improvement of fatigue by addition of natural marine product Fucoidan to the Temozolomide (TMZ) adjuvant chemotherapy for patients with newly diagnosed glioblastoma (GBM)

Abstract INTRODUCTION Glioblastoma (GBM) is the most aggressive primary brain tumor and has a poor prognosis. Patients with GBM not only carry short survival but also suffer from debilitating fatigue due to the tumor and its treatment. Forty-eight percent of patients with newly diagnosed and 90% of patients with recurrent GBM endorse fatigue. Standard chemoradiation therapy is associated with moderate to severe fatigue in 33% of GBM patients. Treatment-and tumor-related fatigue can significantly affect quality of life (QOL), including daily functioning and emotional well-being, and can lead to early treatment termination. Currently, there is no effective treatment for fatigue. Fucoidan, a marine natural product derived from seaweed, is a sulfated polysaccharide. Randomized clinical trials for patients with colon, head and neck, and lung cancers suggest that fucoidan can improve certain adverse events, particularly treatment-related fatigue. Furthermore, studies have shown that fucoidan is well-tolerated with a favorable safety profile. HYPOTHESIS Fucoidan is safe in combination with adjuvant temozolomide and improves tumor-and treatment-related fatigue. METHODS Twelve newly diagnosed GBM patients will be enrolled. They will receive a fucoidan-based product orally at the established MTD dose for GBM patients daily alongside adjuvant temozolomide therapy for six months. Patients will be evaluated weekly to monthly for adverse events (AEs) and quality of life (QOL) scoring. Laboratory and brain MRI monitoring will be performed according to standard of care (SOC) guidelines. Fatigue-associated proinflammatory cytokines, including interleukin (IL)-6, IL-1, and TNF-alpha, will be measured. OUTCOME This pilot study may lay the groundwork for larger randomized clinical trials in the future to treat brain tumors and treatment-related fatigue by incorporating natural products.