Trial Outcomes & Findings for Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme (NCT NCT00243022)
NCT ID: NCT00243022
Last Updated: 2019-04-30
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
at 2 months
Results posted on
2019-04-30
Participant Flow
Patients recruited from September 2004-September 2010 from local medical clinic.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
5
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Difficult Travel Distance
|
0
|
1
|
Baseline Characteristics
Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme
Baseline characteristics by cohort
| Measure |
Arm I (Intervention)
n=7 Participants
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
|
Arm II (Control)
n=5 Participants
Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
cyanocobalamin : 50 ug/daygiven orally
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
30-39 years
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Baseline edema measure
|
10.8 cm^3
STANDARD_DEVIATION 11.1 • n=5 Participants
|
11.3 cm^3
STANDARD_DEVIATION 8.1 • n=7 Participants
|
11.1 cm^3
STANDARD_DEVIATION 9.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: at 2 monthsPopulation: 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.
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
Outcome measures
| Measure |
Arm I (Intervention)
n=4 Participants
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
|
Arm II (Control)
n=2 Participants
Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
cyanocobalamin : 50 ug/daygiven orally
|
|---|---|---|
|
Change From Pooled Baseline in Peritumoral Brain Edema
|
-3.87 cm^3
Standard Deviation 8.0
|
-3.045 cm^3
Standard Deviation 2.14
|
PRIMARY outcome
Timeframe: at 4 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Arm I (Intervention)
n=5 Participants
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
|
Arm II (Control)
n=4 Participants
Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
cyanocobalamin : 50 ug/daygiven orally
|
|---|---|---|
|
Change From Baseline in Peritumoral Brain Edema
|
-2.7 cm^3
Standard Deviation 7.3
|
10.21 cm^3
Standard Deviation 14.06
|
PRIMARY outcome
Timeframe: at 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Arm I (Intervention)
n=2 Participants
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
|
Arm II (Control)
n=2 Participants
Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
cyanocobalamin : 50 ug/daygiven orally
|
|---|---|---|
|
Change From Baseline in Peritumoral Brain Edema
|
-3.7 cm^3
Standard Deviation 9.5
|
-1.5 cm^3
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: At 2, 4, 6, 12, and 24 monthsPopulation: 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.
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)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: All 12 patients followed to progression or death, or censored at last visit when known alive
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.
Outcome measures
| Measure |
Arm I (Intervention)
n=7 Participants
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
|
Arm II (Control)
n=5 Participants
Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
cyanocobalamin : 50 ug/daygiven orally
|
|---|---|---|
|
Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 6 Months
|
43 percentage of participants
Interval -13.0 to 99.0
|
100 percentage of participants
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All 12 patients followed to progression or death, or censored at last visit when known alive
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.
Outcome measures
| Measure |
Arm I (Intervention)
n=7 Participants
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
|
Arm II (Control)
n=5 Participants
Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
cyanocobalamin : 50 ug/daygiven orally
|
|---|---|---|
|
Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 1 Year
|
71 percentage of participants
Interval 32.0 to 111.0
|
80 percentage of participants
Interval 41.0 to 119.0
|
SECONDARY outcome
Timeframe: 1 year.Population: All 12 patients followed to death or censored at last visit when known alive
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.
Outcome measures
| Measure |
Arm I (Intervention)
n=7 Participants
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
|
Arm II (Control)
n=5 Participants
Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
cyanocobalamin : 50 ug/daygiven orally
|
|---|---|---|
|
Overall Survival: Percentage of Patients That Were Alive at 1 Year
|
57 percentage of particpants
Interval 9.0 to 106.0
|
60 percentage of particpants
Interval 5.0 to 115.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At 2, 4, 6, 12, and 24 monthsPopulation: No data collected
The 3-day food diary will be used to assess the dietary intake and to increase eating awareness of patients.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Intervention)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm II (Control)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Intervention)
n=7 participants at risk
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
|
Arm II (Control)
n=5 participants at risk
Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
cyanocobalamin : 50 ug/daygiven orally
|
|---|---|---|
|
Nervous system disorders
Seizure
|
0.00%
0/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected over a 4 year period while patients were on treatment
|
Other adverse events
| Measure |
Arm I (Intervention)
n=7 participants at risk
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
|
Arm II (Control)
n=5 participants at risk
Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
cyanocobalamin : 50 ug/daygiven orally
|
|---|---|---|
|
General disorders
Tiredness
|
28.6%
2/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
40.0%
2/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Gastrointestinal disorders
Heartburn
|
14.3%
1/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
0.00%
0/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
14.3%
1/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
0.00%
0/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
1/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
0.00%
0/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
General disorders
Weight Loss
|
14.3%
1/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
0.00%
0/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
28.6%
2/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
40.0%
2/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
14.3%
1/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
0.00%
0/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Skin and subcutaneous tissue disorders
Radiation Dermatitis
|
14.3%
1/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
20.0%
1/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Skin and subcutaneous tissue disorders
Shingles
|
14.3%
1/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
0.00%
0/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Endocrine disorders
Cushingoid appearance
|
14.3%
1/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
0.00%
0/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
0.00%
0/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
1/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
0.00%
0/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Gastrointestinal disorders
Thrush
|
14.3%
1/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
0.00%
0/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Gastrointestinal disorders
Hemorrhoids
|
14.3%
1/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
0.00%
0/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Gastrointestinal disorders
Rectal bleeding
|
14.3%
1/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
0.00%
0/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
1/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
0.00%
0/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
1/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
0.00%
0/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
14.3%
1/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
0.00%
0/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Psychiatric disorders
Ataxia
|
14.3%
1/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
0.00%
0/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
20.0%
1/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Psychiatric disorders
Mood alteration-anxiety, agitation
|
28.6%
2/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
20.0%
1/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Nervous system disorders
Neuropathy-sensory
|
14.3%
1/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
0.00%
0/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Psychiatric disorders
Disoriented; cries easily; angry
|
14.3%
1/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
0.00%
0/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Nervous system disorders
Neck pain
|
0.00%
0/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
20.0%
1/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
14.3%
1/7 • Adverse event data was collected over a 4 year period while patients were on treatment
|
0.00%
0/5 • Adverse event data was collected over a 4 year period while patients were on treatment
|
Additional Information
Dr. Glen Stevens
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place