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Sponsors and Collaborators: |
The Cleveland Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00243022 |
RATIONALE: Giving the herbBoswellia 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 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.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors Cancer-Related Problem/Condition |
Dietary Supplement: Boswellia serrata extract Dietary Supplement: cyanocobalamin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Phase II Randomized Evaluation of 5-Lipoxygenase Inhibition by Herbal Medicine Approach Compared to Control as an Adjuvant Therapy in Newly Diagnosed and Recurrent High-Grade Gliomas |
Estimated Enrollment: | 70 |
Study Start Date: | August 2005 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I (intervention): Experimental
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.
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Dietary Supplement: Boswellia serrata extract
given orally
Dietary Supplement: cyanocobalamin
given orally
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Arm II (control): Active Comparator
Patients receive oral vitamin B 12 once a day for 6 months.
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Dietary Supplement: cyanocobalamin
given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This a randomized, controlled study. Patients are stratified according to age (< 65 years vs > 65 years) and Karnofsky performance status (70-80% vs 90-100%). Patients are randomized to 1 of 2 treatment arms.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed high-grade glioma of 1 of the following types:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No other concurrent herbal preparations containing 5-lipoxygenase inhibitors, including any of the following:
United States, Ohio | |
Cleveland Clinic Taussig Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100 |
Study Chair: | Glen H. J. Stevens, DO, PhD | The Cleveland Clinic |
Responsible Party: | Cleveland Clinic Taussig Cancer Center ( Glen H. J. Stevens ) |
Study ID Numbers: | CDR0000445603, CASE-CCF-7348, CCF-7348 |
Study First Received: | October 20, 2005 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00243022 History of Changes |
Health Authority: | Unspecified |
cerebral edema adult glioblastoma adult giant cell glioblastoma |
adult gliosarcoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma |
Glioblastoma Vitamin B Complex Astrocytoma Hematinics Hydroxocobalamin Adjuvants, Immunologic Edema Vitamin B 12 Trace Elements |
Central Nervous System Neoplasms Recurrence Vitamins Oligodendroglioma Micronutrients Glioma Gliosarcoma Nervous System Neoplasms |
Vitamin B Complex Hematinics Growth Substances Hematologic Agents Nervous System Diseases Hydroxocobalamin Physiological Effects of Drugs Vitamin B 12 |
Central Nervous System Neoplasms Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Micronutrients Nervous System Neoplasms |