NCT00243022

Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Ali Altunkaya · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Brain and Central Nervous System Tumors
• Cerebral Edema

Interventions

Type	Name	Description
DRUG	Boswellia serrata extract	given orally
DIETARY_SUPPLEMENT	cyanocobalamin	given orally

Timeline

• Start date: 2004-09-01
• Primary completion: 2010-03-01
• Completion: 2011-03-01
• First posted: 2005-10-21
• Last updated: 2019-04-30
• Results posted: 2013-07-30

Locations

1 site across 1 country: United States