Name of the Trial
Phase II Randomized Study of Adjuvant Boswellia serrata Combined with a Low-Fat, Arachidonic Acid-Free Vegan Diet Versus a Standard Diet Alone in Patients with Newly Diagnosed or Recurrent High-Grade Gliomas (CASE-CCF-7348). See the protocol summary at http://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 and eat a low-fat vegan diet for 6 months or to eat a normal low-fat diet for 6 months. Vegan diets lack arachidonic acid, a chemical found in meat that is converted in the brain to signaling molecules called eicosanoids that may promote inflammation and tumor growth. Doctors want to see if B. serrata and a vegan diet can help reduce brain edema, tumor growth, and levels of 5-lipoxygenase, an enzyme that helps convert arachidonic acid to eicosanoids, in these patients.

"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 dietary changes in conjunction with use of this herbal preparation will help improve patient outcomes and act in a complementary fashion with standard treatments for high-grade gliomas."

Who Can Join This Trial
Researchers will enroll 70 patients aged 18 and over with newly diagnosed or recurrent high-grade glioma who have undergone surgery to remove their cancer. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/CASE-CCF-7348.

Study Site and Contact Information
This trial is being conducted at the Cleveland Clinic Taussig Cancer Center. For more information, call the Taussig Cancer Center toll free at 1-800-862-7798.