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
|Phase II||Treatment||Active||18 and over||NCI||CASE-CCF-7348|
CCF-7348, NCT00243022, CASE1304200
Special Category: NCI Web site featured trial
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.
This randomized phase II trial is studying Boswellia serrata and standard treatment to see how well it works compared to standard treatment alone in treating patients who have undergone surgery and radiation therapy for newly diagnosed or recurrent high-grade gliomas.
Eligibility criteria include the following:
- At least 18 years old
- Has undergone previous surgery and radiation therapy
- For more information about the eligibility criteria for this trial, refer to the Health Professional version.
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.
Patients in group one will receive Boswellia serrata by mouth 4 times a day and vitamin B12 by mouth once a day for 6 months.
Patients in group two will receive vitamin B12 by mouth once a day for 6 months.
All patients will be encouraged to eat a regular balanced diet with limited red meats or processed meats.
Quality of life will be assessed periodically. After finishing treatment, patients will be evaluated every 6 months.
For more details about this trial, refer to the Health Professional version of the trial summary.
If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.
Trial Lead Organizations
Cleveland Clinic Taussig Cancer Center
|Glen Stevens, DO, PhD, Protocol chair|
|Cleveland Clinic Taussig Cancer Center|
|Clinical Trials Office - Cleveland Clinic Taussig Cancer Center|
|Official Title||Phase II Randomized Evaluation of 5-Lipoxygenase Inhibition by Boswellia serrata Herbal Medicine Approach Compared to Control as an Adjuvant Therapy in Newly Diagnosed and Recurrent High-grade Gliomas|
|Trial Start Date||2005-08-18|
|Trial Completion Date||2009-09-09 (estimated)|
|Registered in ClinicalTrials.gov||NCT00243022|
|Date Submitted to PDQ||2005-08-19|
|Information Last Verified||2008-10-22|
|NCI Grant/Contract Number||CA107277, CA43703|