Phase II Randomized Evaluation of 5-Lipoxygenase Inhibition by Herbal Complementary and Alternative Medicine Approach Compared to Control as an Adjuvant Therapy in Newly Diagnosed and Recurrent High-grade Gliomas
- To determine whether a herbal approach to decreasing 5-LO eicosanoid production reduces
peritumoral brain edema in patients with HGG.
- To determine if this adjuvant approach improves the quality of life and progression
free and overall survival of patients with HGG.
OUTLINE: This a randomized, controlled study. Patients are randomized to 1 of 2 treatment
- Arm I (intervention): Patients receive oral Boswellia serrata herbal extract 4 times a
day and oral cyanocobalamin (vitamin B-12) once a day for 6 months in the absence of
- Arm II (control): Patients receive oral vitamin B-12 once a day for 6 months. All
patients are encouraged to eat a regular balanced diet (as recommended by the American
Cancer Society for cancer prevention) with limited consumption of red and processed
Quality of life will be assessed at baseline and then at 2, 4, 6, 12, and 24 months.
After completion of study treatment, patients will be followed every 6 months.
PROJECTED ACCRUAL: A total of 70 patients (35 per treatment arm) will be accrued for this
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Change from baseline in peritumoral brain edema
The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation.
at 2 months
Glen Stevens, DO, PhD
The Cleveland Clinic
United States: Food and Drug Administration
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|