A Phase 2 interventional study of Boswellia serrata extract and cyanocobalamin in Brain and Central Nervous System Tumors and Cerebral Edema, sponsored by Ali Altunkaya. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-30.
Sponsored by Ali Altunkaya · Phase 2, Interventional, and Treatment
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.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 12 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →This is the only study on the registry with Ali Altunkaya as lead sponsor.
Counted across the registry records on this site, refreshed daily.
EXCLUSION CRITERIA:
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.
Drug: Boswellia serrata extract · Dietary Supplement: cyanocobalamin
Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
Dietary Supplement: cyanocobalamin
given orally
given orally
Also known as: Vitamin B12
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
Time frame: 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.
Time frame: 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.
Time frame: at 6 months
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 frame: At 2, 4, 6, 12, and 24 months
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 frame: 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.
Time frame: 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.
Time frame: 1 year.
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.
Time frame: At 2, 4, 6, 12, and 24 months
Patients recruited from September 2004-September 2010 from local medical clinic.
| Milestone | Arm I (Intervention) | Arm II (Control) |
|---|---|---|
| Started | 7 | 5 |
| Completed | 5 | 4 |
| Not completed | 2 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Difficult travel distance | 0 | 1 |
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
| cm^3 | Arm I (Intervention) | Arm II (Control) |
|---|---|---|
| Change From Pooled Baseline in Peritumoral Brain Edema | -3.87 ± 8.0 | -3.045 ± 2.14 |
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.
| cm^3 | Arm I (Intervention) | Arm II (Control) |
|---|---|---|
| Change From Baseline in Peritumoral Brain Edema | -2.7 ± 7.3 | 10.21 ± 14.06 |
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.
| cm^3 | Arm I (Intervention) | Arm II (Control) |
|---|---|---|
| Change From Baseline in Peritumoral Brain Edema | -3.7 ± 9.5 | -1.5 ± 2.9 |
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)
No measurements were reported for this outcome.
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.
| percentage of participants | Arm I (Intervention) | Arm II (Control) |
|---|---|---|
| Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 6 Months | 43 (-13 to 99) | 100 (100 to 100) |
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.
| percentage of participants | Arm I (Intervention) | Arm II (Control) |
|---|---|---|
| Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 1 Year | 71 (32 to 111) | 80 (41 to 119) |
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.
| percentage of particpants | Arm I (Intervention) | Arm II (Control) |
|---|---|---|
| Overall Survival: Percentage of Patients That Were Alive at 1 Year | 57 (9 to 106) | 60 (5 to 115) |
The 3-day food diary will be used to assess the dietary intake and to increase eating awareness of patients.
No measurements were reported for this outcome.
Collected over Adverse event data was collected over a 4 year period while patients were on treatment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I (Intervention) | — | 0/7 (0%) | 3/7 (42.9%) |
| Arm II (Control) | — | 2/5 (40%) | 3/5 (60%) |
| Event | Arm I (Intervention) | Arm II (Control) |
|---|---|---|
| SeizureNervous system disorders | 0/7 | 1/5 |
| PsychosisPsychiatric disorders | 0/7 | 1/5 |
| Event | Arm I (Intervention) | Arm II (Control) |
|---|---|---|
| TirednessGeneral disorders | 2/7 | 2/5 |
| AlopeciaSkin and subcutaneous tissue disorders | 2/7 | 2/5 |
| ConstipationGastrointestinal disorders | 2/7 | 0/5 |
| Mood alteration-anxiety, agitationPsychiatric disorders | 2/7 | 1/5 |
| Radiation DermatitisSkin and subcutaneous tissue disorders | 1/7 | 1/5 |
| InsomniaPsychiatric disorders | 0/7 | 1/5 |
| Neck painNervous system disorders | 0/7 | 1/5 |
| HeartburnGastrointestinal disorders | 1/7 | 0/5 |
| Skin RashSkin and subcutaneous tissue disorders | 1/7 | 0/5 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/7 | 0/5 |
| Age, Customized(participants) | Arm I (Intervention) | Arm II (Control) | Total |
|---|---|---|---|
| 30-39 years | 1 | 0 | 1 |
| 40-49 years | 3 | 3 | 6 |
| 50-59 years | 1 | 2 | 3 |
| 60-69 years | 1 | 0 | 1 |
| 70-79 years | 1 | 0 | 1 |
| Sex: Female, Male(Participants) | Arm I (Intervention) | Arm II (Control) | Total |
|---|---|---|---|
| Female | 4 | 2 | 6 |
| Male | 3 | 3 | 6 |
| Ethnicity (NIH/OMB)(Participants) | Arm I (Intervention) | Arm II (Control) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 7 | 5 | 12 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Arm I (Intervention) | Arm II (Control) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 7 | 4 | 11 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Arm I (Intervention) | Arm II (Control) | Total |
|---|---|---|---|
| United States | 7 | 5 | 12 |
| Baseline edema measure(cm^3) | Arm I (Intervention) | Arm II (Control) | Total |
|---|---|---|---|
| Mean | 10.8 ± 11.1 | 11.3 ± 8.1 | 11.1 ± 9.4 |
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