Back to resultsDietary, Herbal and Alternative Medicine in Glioblastoma Multiforme
Primary Purpose
Brain and Central Nervous System Tumors, Cerebral Edema
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Boswellia serrata extract
cyanocobalamin
Sponsored by
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring cerebral edema, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma
Eligibility Criteria
INCLUSION CRITERIA: Patients after surgical removal of histologically confirmed World Health Organization high-grade gliomas, including astrocytomas grade III (anaplastic astrocytoma), astrocytoma grade IV (glioblastoma multiforme, GBM), anaplastic oligodendroglioma and oligoastrocytoma Karnofsky performance status of greater or equal 60 Patients who signed informed consent Patients can be receiving standard or investigational chemotherapy , hormonal therapy, immunotherapy or biologic agents as the primary treatment for their tumor Glucocorticoid therapy is allowed Bone marrow function (absolute neutrophil count [ANC] >=1500/mm^3 and platelet count >=75,000/mm^3); in the event of plate count dropping below 50,000/ mm^3 the Boswellia will be withdrawn until plate count reaches 75,000 mm^3 and above Liver function (bilirubin and alkaline phosphatase =< 2 x normal and serum glutamic oxaloacetic transaminase [SGOT] =< 3 x normal) Renal function (blood urea nitrogen [BUN] or creatinine =< 1.5 x normal) Patients suffering from mild to moderate asthma, liver and kidney disease; an assessment of the condition will be made to establish a baseline and monitor progress at 4 weekly intervals to start with for the first two months and thereafter at the usual study intervals of 4 and 6 months; if there is any significant deterioration in their condition the Boswellia will be withdrawn until these parameters are restored to their pre-treatment levels EXCLUSION CRITERIA: Any medical condition that could interfere with eating and oral administration of B. serrata Patients already taking herbal preparations that contain 5-LO inhibitors Any previous (within the past 3 years) or concurrent malignancies at other sites, with the exception of surgically cured carcinoma-in-situ of the cervix and non-melanoma skin cancer Pregnancy and breastfeeding Active infection Inability to be followed closely at the Cleveland Clinic Foundation
Sites / Locations
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm I (intervention)
Arm II (control)
Arm Description
Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.
Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
Outcomes
Primary Outcome Measures
Change From Pooled Baseline in Peritumoral Brain Edema
The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation. For each patient change = edema at follow up - baseline edema
Change From Baseline in Peritumoral Brain Edema
The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation.For each patient change = edema at follow up - baseline edema.
Change From Baseline in Peritumoral Brain Edema
The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation. For each patient change = edema at follow up - baseline edema.
Secondary Outcome Measures
Quality of Life at 6 Months
Quality of life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Items (EORTC QLQ-C30)
Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 6 Months
Percentage of participants with tumor progression (>25% increase in tumor volume compared to time 0) will be measured from enrollment to documented progression or death whichever comes first. The method used to calculate the time to tumor progression was Kaplan Meier test method to define the 95% confidence levels.
Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 1 Year
Percentage of participants with tumor progression (>25% increase in tumor volume compared to time 0) will be measured from enrollment to documented progression or death whichever comes first. The method used to calculate the time to tumor progression was Kaplan Meier test method to define the 95% confidence levels.
Overall Survival: Percentage of Patients That Were Alive at 1 Year
Overall survival will be measured from the date of enrollment to date of death or last contact. Survival will be evaluated by the Kaplan Meier method to evaluate the median survival and 1 year survival rates.
Full Information
NCT ID
NCT00243022
First Posted
October 20, 2005
Last Updated
April 21, 2019
Sponsor
Ali Altunkaya
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00243022
Brief Title
Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
September 2004 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ali Altunkaya
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Cerebral Edema
Keywords
cerebral edema, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I (intervention)
Arm Type
Experimental
Arm Description
Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.
Arm Title
Arm II (control)
Arm Type
Active Comparator
Arm Description
Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
Intervention Type
Drug
Intervention Name(s)
Boswellia serrata extract
Intervention Description
given orally
Intervention Type
Dietary Supplement
Intervention Name(s)
cyanocobalamin
Other Intervention Name(s)
Vitamin B12
Intervention Description
given orally
Primary Outcome Measure Information:
Title
Change From Pooled Baseline in Peritumoral Brain Edema
Description
The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation. For each patient change = edema at follow up - baseline edema
Time Frame
at 2 months
Title
Change From Baseline in Peritumoral Brain Edema
Description
The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation.For each patient change = edema at follow up - baseline edema.
Time Frame
at 4 months
Title
Change From Baseline in Peritumoral Brain Edema
Description
The relative change from baseline will be assessed longitudinally, however, the main comparison of interest is the relative change at the 4-month evaluation. For each patient change = edema at follow up - baseline edema.
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
Quality of Life at 6 Months
Description
Quality of life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Items (EORTC QLQ-C30)
Time Frame
At 2, 4, 6, 12, and 24 months
Title
Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 6 Months
Description
Percentage of participants with tumor progression (>25% increase in tumor volume compared to time 0) will be measured from enrollment to documented progression or death whichever comes first. The method used to calculate the time to tumor progression was Kaplan Meier test method to define the 95% confidence levels.
Time Frame
6 months
Title
Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 1 Year
Description
Percentage of participants with tumor progression (>25% increase in tumor volume compared to time 0) will be measured from enrollment to documented progression or death whichever comes first. The method used to calculate the time to tumor progression was Kaplan Meier test method to define the 95% confidence levels.
Time Frame
1 year
Title
Overall Survival: Percentage of Patients That Were Alive at 1 Year
Description
Overall survival will be measured from the date of enrollment to date of death or last contact. Survival will be evaluated by the Kaplan Meier method to evaluate the median survival and 1 year survival rates.
Time Frame
1 year.
Other Pre-specified Outcome Measures:
Title
Food Intake as Assessed by the Block 98 Food Frequency Questionnaire and a 3-day Food Record
Description
The 3-day food diary will be used to assess the dietary intake and to increase eating awareness of patients.
Time Frame
At 2, 4, 6, 12, and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA:
Patients after surgical removal of histologically confirmed World Health Organization high-grade gliomas, including astrocytomas grade III (anaplastic astrocytoma), astrocytoma grade IV (glioblastoma multiforme, GBM), anaplastic oligodendroglioma and oligoastrocytoma
Karnofsky performance status of greater or equal 60
Patients who signed informed consent
Patients can be receiving standard or investigational chemotherapy , hormonal therapy, immunotherapy or biologic agents as the primary treatment for their tumor
Glucocorticoid therapy is allowed
Bone marrow function (absolute neutrophil count [ANC] >=1500/mm^3 and platelet count >=75,000/mm^3); in the event of plate count dropping below 50,000/ mm^3 the Boswellia will be withdrawn until plate count reaches 75,000 mm^3 and above
Liver function (bilirubin and alkaline phosphatase =< 2 x normal and serum glutamic oxaloacetic transaminase [SGOT] =< 3 x normal)
Renal function (blood urea nitrogen [BUN] or creatinine =< 1.5 x normal)
Patients suffering from mild to moderate asthma, liver and kidney disease; an assessment of the condition will be made to establish a baseline and monitor progress at 4 weekly intervals to start with for the first two months and thereafter at the usual study intervals of 4 and 6 months; if there is any significant deterioration in their condition the Boswellia will be withdrawn until these parameters are restored to their pre-treatment levels
EXCLUSION CRITERIA:
Any medical condition that could interfere with eating and oral administration of B. serrata
Patients already taking herbal preparations that contain 5-LO inhibitors
Any previous (within the past 3 years) or concurrent malignancies at other sites, with the exception of surgically cured carcinoma-in-situ of the cervix and non-melanoma skin cancer
Pregnancy and breastfeeding
Active infection
Inability to be followed closely at the Cleveland Clinic Foundation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glen Stevens, DO, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme
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