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| ID | Type | Description | Link |
|---|---|---|---|
| CCF-7348 | Other Identifier | Cleveland Clinic IRB | |
| NCI-2010-01384 | Other Identifier | NCI/CTRP | |
| R21CA107277-01 | U.S. NIH Grant/Contract | View source |
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Slow accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This a randomized, controlled study. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (intervention) | Experimental | 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 II (control) | Active Comparator | Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boswellia serrata extract | Drug | given orally |
| |
| cyanocobalamin |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 2 months |
| 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. | at 4 months |
| 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. | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | At 2, 4, 6, 12, and 24 months |
| Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Food Intake as Assessed by the Block 98 Food Frequency Questionnaire and a 3-day Food Record | The 3-day food diary will be used to assess the dietary intake and to increase eating awareness of patients. | At 2, 4, 6, 12, and 24 months |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Glen Stevens, DO, PhD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
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Patients recruited from September 2004-September 2010 from local medical clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Intervention) | 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. cyanocobalamin : 50 ug/day given orally Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day |
| FG001 | Arm II (Control) | Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months. cyanocobalamin : 50 ug/day given orally |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Intervention) | 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. cyanocobalamin : 50 ug/day given orally Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Patients with baseline and follow up peritumoral edema measurement. Closest measurement to time point was used. When 4 month was not available last prior was used. | Posted | Mean | Standard Deviation | cm^3 | at 2 months |
|
Adverse event data was collected over a 4 year period while patients were on treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Intervention) | 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. cyanocobalamin : 50 ug/day given orally Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment | Unrelated to intervention |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tiredness | General disorders | CTCAE (2.0) | Non-systematic Assessment |
Certain outcome analysis not done due to low patient accrual.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Glen Stevens | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | steveng@ccf.org |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D001929 | Brain Edema |
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| D001254 | Astrocytoma |
| D009837 | Oligodendroglioma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065260 | Frankincense |
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D012116 | Resins, Plant |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| Dietary Supplement |
given orally |
|
|
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. |
| 6 months |
| 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. | 1 year |
| 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. | 1 year. |
| Difficult Travel Distance |
|
| BG001 |
| Arm II (Control) |
Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months. cyanocobalamin : 50 ug/daygiven orally |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline edema measure | Baseline measure was acquired for 11 patients. Six on Arm I and five on Arm II. | Mean | Standard Deviation | cm^3 |
|
| OG001 | Arm II (Control) | Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months. cyanocobalamin : 50 ug/daygiven orally |
|
|
|
| Primary | 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. | Patients with baseline and follow up peritumoral edema measurement. Closest measurement to time point was used. When 4 month was not available last prior was used. | Posted | Mean | Standard Deviation | cm^3 | at 4 months |
|
|
|
|
| Primary | 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. | Patients with baseline and follow up peritumoral edema measurement. Closest measurement to time point was used. When 4 month was not available last prior was used. | Posted | Mean | Standard Deviation | cm^3 | at 6 months |
|
|
|
|
| Secondary | 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) | At baseline and the most recent post treatment point in time, the QOL data for group 1 consist of n=3 patients and for group 2, n=2. Because of low patient numbers, no analysis was done. | Posted | At 2, 4, 6, 12, and 24 months |
|
|
| Secondary | 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. | All 12 patients followed to progression or death, or censored at last visit when known alive | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
|
|
| Secondary | 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. | All 12 patients followed to progression or death, or censored at last visit when known alive | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
|
|
| Secondary | 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. | All 12 patients followed to death or censored at last visit when known alive | Posted | Number | 95% Confidence Interval | percentage of particpants | 1 year. |
|
|
|
| Other Pre-specified | Food Intake as Assessed by the Block 98 Food Frequency Questionnaire and a 3-day Food Record | The 3-day food diary will be used to assess the dietary intake and to increase eating awareness of patients. | No data collected | Posted | At 2, 4, 6, 12, and 24 months |
|
|
| 0 |
| 7 |
| 3 |
| 7 |
| EG001 | Arm II (Control) | Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months. cyanocobalamin : 50 ug/daygiven orally | 2 | 5 | 3 | 5 |
|
| Psychosis | Psychiatric disorders | CTCAE (2.0) | Non-systematic Assessment | Unrelated to intervention |
|
| Heartburn | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Skin Rash | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Weight Loss | General disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Radiation Dermatitis | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Shingles | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Cushingoid appearance | Endocrine disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Thrush | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Rectal bleeding | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Ataxia | Psychiatric disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Mood alteration-anxiety, agitation | Psychiatric disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Neuropathy-sensory | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Disoriented; cries easily; angry | Psychiatric disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Neck pain | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Asthma exacerbation | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
|
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D053147 |
| Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |