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Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme

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ClinicalTrials.gov Identifier: NCT00243022
Recruitment Status : Terminated (Slow accrual)
First Posted : October 21, 2005
Results First Posted : July 30, 2013
Last Update Posted : July 30, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ali Altunkaya, Case Comprehensive Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Brain and Central Nervous System Tumors
Cerebral Edema
Interventions Drug: Boswellia serrata extract
Dietary Supplement: cyanocobalamin
Enrollment 12
Recruitment Details Patients recruited from September 2004-September 2010 from local medical clinic.
Pre-assignment Details  
Arm/Group Title Arm I (Intervention) Arm II (Control)
Hide Arm/Group 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.

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

Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.

cyanocobalamin : 50 ug/day given orally

Period Title: Overall Study
Started 7 5
Completed 5 4
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             1             0
Death             1             0
Difficult Travel Distance             0             1
Arm/Group Title Arm I (Intervention) Arm II (Control) Total
Hide Arm/Group 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.

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

Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.

cyanocobalamin : 50 ug/daygiven orally

Total of all reporting groups
Overall Number of Baseline Participants 7 5 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
Female
4
  57.1%
2
  40.0%
6
  50.0%
Male
3
  42.9%
3
  60.0%
6
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
7
 100.0%
5
 100.0%
12
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  20.0%
1
   8.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
7
 100.0%
4
  80.0%
11
  91.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 5 participants 12 participants
7 5 12
Baseline edema measure   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm^3
Number Analyzed 7 participants 5 participants 12 participants
10.8  (11.1) 11.3  (8.1) 11.1  (9.4)
[1]
Measure Description: Baseline measure was acquired for 11 patients. Six on Arm I and five on Arm II.
1.Primary Outcome
Title Change From Pooled Baseline in Peritumoral Brain Edema
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm I (Intervention) Arm II (Control)
Hide Arm/Group 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.

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

Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.

cyanocobalamin : 50 ug/daygiven orally

Overall Number of Participants Analyzed 4 2
Mean (Standard Deviation)
Unit of Measure: cm^3
-3.87  (8.0) -3.045  (2.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Intervention), Arm II (Control)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Peritumoral Brain Edema
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm I (Intervention) Arm II (Control)
Hide Arm/Group 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.

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

Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.

cyanocobalamin : 50 ug/daygiven orally

Overall Number of Participants Analyzed 5 4
Mean (Standard Deviation)
Unit of Measure: cm^3
-2.7  (7.3) 10.21  (14.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Intervention), Arm II (Control)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline in Peritumoral Brain Edema
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm I (Intervention) Arm II (Control)
Hide Arm/Group 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.

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

Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.

cyanocobalamin : 50 ug/daygiven orally

Overall Number of Participants Analyzed 2 2
Mean (Standard Deviation)
Unit of Measure: cm^3
-3.7  (9.5) -1.5  (2.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Intervention), Arm II (Control)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Quality of Life at 6 Months
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm I (Intervention) Arm II (Control)
Hide Arm/Group 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.

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

Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.

cyanocobalamin : 50 ug/daygiven orally

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 6 Months
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All 12 patients followed to progression or death, or censored at last visit when known alive
Arm/Group Title Arm I (Intervention) Arm II (Control)
Hide Arm/Group 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.

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

Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.

cyanocobalamin : 50 ug/daygiven orally

Overall Number of Participants Analyzed 7 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
43
(-13 to 99)
100
(100 to 100)
6.Secondary Outcome
Title Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 1 Year
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All 12 patients followed to progression or death, or censored at last visit when known alive
Arm/Group Title Arm I (Intervention) Arm II (Control)
Hide Arm/Group 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.

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

Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.

cyanocobalamin : 50 ug/daygiven orally

Overall Number of Participants Analyzed 7 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
71
(32 to 111)
80
(41 to 119)
7.Secondary Outcome
Title Overall Survival: Percentage of Patients That Were Alive at 1 Year
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All 12 patients followed to death or censored at last visit when known alive
Arm/Group Title Arm I (Intervention) Arm II (Control)
Hide Arm/Group 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.

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

Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.

cyanocobalamin : 50 ug/daygiven orally

Overall Number of Participants Analyzed 7 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of particpants
57
(9 to 106)
60
(5 to 115)
8.Secondary Outcome
Title Food Intake as Assessed by the Block 98 Food Frequency Questionnaire and a 3-day Food Record
Hide 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
Outcome Measure Data Not Reported
Time Frame Adverse event data was collected over a 4 year period while patients were on treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Intervention) Arm II (Control)
Hide Arm/Group 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.

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

Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.

cyanocobalamin : 50 ug/daygiven orally

All-Cause Mortality
Arm I (Intervention) Arm II (Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Intervention) Arm II (Control)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      2/5 (40.00%)    
Nervous system disorders     
Seizure * 1 [1]  0/7 (0.00%)  0 1/5 (20.00%)  1
Psychiatric disorders     
Psychosis * 1 [1]  0/7 (0.00%)  0 1/5 (20.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
[1]
Unrelated to intervention
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Intervention) Arm II (Control)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/7 (42.86%)      3/5 (60.00%)    
Blood and lymphatic system disorders     
Thrombocytopenia * 1  1/7 (14.29%)  0/5 (0.00%) 
Endocrine disorders     
Cushingoid appearance * 1  1/7 (14.29%)  0/5 (0.00%) 
Gastrointestinal disorders     
Heartburn * 1  1/7 (14.29%)  0/5 (0.00%) 
Constipation * 1  2/7 (28.57%)  0/5 (0.00%) 
Diarrhea * 1  1/7 (14.29%)  0/5 (0.00%) 
Thrush * 1  1/7 (14.29%)  0/5 (0.00%) 
Hemorrhoids * 1  1/7 (14.29%)  0/5 (0.00%) 
Rectal bleeding * 1  1/7 (14.29%)  0/5 (0.00%) 
General disorders     
Tiredness * 1  2/7 (28.57%)  2/5 (40.00%) 
Weight Loss * 1  1/7 (14.29%)  0/5 (0.00%) 
Metabolism and nutrition disorders     
Hypokalemia * 1  1/7 (14.29%)  0/5 (0.00%) 
Hyperglycemia * 1  1/7 (14.29%)  0/5 (0.00%) 
Hypertriglyceridemia * 1  1/7 (14.29%)  0/5 (0.00%) 
Nervous system disorders     
Neuropathy-sensory * 1  1/7 (14.29%)  0/5 (0.00%) 
Neck pain * 1  0/7 (0.00%)  1/5 (20.00%) 
Psychiatric disorders     
Ataxia * 1  1/7 (14.29%)  0/5 (0.00%) 
Insomnia * 1  0/7 (0.00%)  1/5 (20.00%) 
Mood alteration-anxiety, agitation * 1  2/7 (28.57%)  1/5 (20.00%) 
Disoriented; cries easily; angry * 1  1/7 (14.29%)  0/5 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma exacerbation * 1  1/7 (14.29%)  0/5 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin Rash * 1  1/7 (14.29%)  0/5 (0.00%) 
Alopecia * 1  2/7 (28.57%)  2/5 (40.00%) 
Dry Skin * 1  1/7 (14.29%)  0/5 (0.00%) 
Radiation Dermatitis * 1  1/7 (14.29%)  1/5 (20.00%) 
Shingles * 1  1/7 (14.29%)  0/5 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain outcome analysis not done due to low patient accrual.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Glen Stevens
Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Responsible Party: Ali Altunkaya, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00243022     History of Changes
Other Study ID Numbers: CASE1304
CCF-7348 ( Other Identifier: Cleveland Clinic IRB )
NCI-2010-01384 ( Other Identifier: NCI/CTRP )
R21CA107277-01 ( U.S. NIH Grant/Contract )
First Submitted: October 20, 2005
First Posted: October 21, 2005
Results First Submitted: October 11, 2012
Results First Posted: July 30, 2013
Last Update Posted: July 30, 2013