Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243022
Status:
TERMINATED
Last Update Posted:
2019-04-30
First Post:
2005-10-20
Brief Title:
Dietary Herbal and Alternative Medicine in Glioblastoma Multiforme
Sponsor:
Ali Altunkaya
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
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
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CCF-7348 | OTHER | None | None |
| NCI-2010-01384 | OTHER | None | None |
| R21CA107277-01 | NIH | NCICTRP | httpsreporternihgovquickSearchR21CA107277-01 |