Name of the Trial
Phase II Randomized Study of Adjuvant Boswellia Serrata and Standard Treatment Versus Standard Treatment Alone in Patients with Newly Diagnosed or Recurrent High-Grade Gliomas (CASE-CCF-7348). See the protocol summary at http://www.cancer.gov/clinicaltrials/CASE-CCF-7348.

Principal Investigator
Dr. Glen Stevens, Cleveland Clinic Foundation

Why This Trial Is Important
High-grade gliomas are among the most common and aggressive forms of adult brain cancer. Swelling of the brain (brain edema) is an often debilitating symptom of glioma and may continue to affect patients even if the tumor is surgically removed.

Resin from the Boswellia serrata tree (frankincense) has been shown in animal and human studies to reduce inflammation, which is a primary cause of brain edema. Additionally, laboratory studies suggest that B. serrata resin may also cause human brain cancer cells to undergo programmed cell death (apoptosis).

In this trial, patients will be randomly assigned to take an herbal preparation of B. serrata orally four times a day in conjunction with standard treatment for six months or to take standard treatment alone for six months. All patients are advised to eat a low-fat healthy diet. Diets rich in red meat contain a substance called arachidonic acid, and chemicals in fat can be converted to arachidonic acid. Arachidonic acid is converted in the brain to signaling molecules called eicosanoids that may promote inflammation and tumor growth. Doctors want to see if B. serrata can help reduce brain edema, tumor growth, and levels of 5-lipoxygenase, an enzyme that helps convert arachidonic acid to eicosanoids, in these patients when combined with standard treatment.

"Some small studies have suggested that frankincense extract may help limit brain edema and even have an anti-tumor effect,” said Dr. Stevens. "We hope that use of this herbal preparation in conjunction with a healthy diet will help improve patient outcomes and act in a complementary fashion with standard treatments for high-grade gliomas."

For More Information
See the lists of entry criteria and trial contact information at http://cancer.gov/clinicaltrials/CASE-CCF-7348 or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The toll-free call is confidential.