Brain and Central Nervous System Tumors Clinical Trial
Official title:
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
RATIONALE: Giving the herb Boswellia serrata after surgery and radiation therapy may slow the
growth of any remaining tumor cells. It is not yet known whether giving Boswellia serrata
together with standard treatment is more effective than standard treatment alone in treating
high-grade gliomas.
PURPOSE: This randomized phase II trial is the study of a combination of complementary and
alternative medicine (CAM) herbal supplement intervention as an adjuvant to standard
treatment of patients with newly diagnosed and recurrent high-grade gliomas (HGG). The
central hypothesis of this application is that a herbal preparation that inhibits 5-LO
activity, will produce measurable biologically meaningful decrease in 5-LO eicosanoid
production and brain edema that will be associated with improved survival and quality of life
in patients with HGG.
OBJECTIVES:
Primary
- To determine whether a herbal approach to decreasing 5-LO eicosanoid production reduces
peritumoral brain edema in patients with HGG.
Secondary
- 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
arms.
- 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
unacceptable toxicity.
- 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
meats.
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
study.
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