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Trial record 30 of 287 for:    complementary and alternative medicine

Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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:
Information provided by (Responsible Party):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients recruited from September 2004-September 2010 from local medical clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Arm I (Intervention)   Arm II (Control)
STARTED   7   5 
COMPLETED   5   4 
NOT COMPLETED   2   1 
Withdrawal by Subject                1                0 
Death                1                0 
Difficult Travel Distance                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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/daygiven orally

Total Total of all reporting groups

Baseline Measures
   Arm I (Intervention)   Arm II (Control)   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   5   12 
Age, Customized 
[Units: 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 
Gender 
[Units: Participants]
     
Female   4   2   6 
Male   3   3   6 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   0   0   0 
Not Hispanic or Latino   7   5   12 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
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 
[Units: Participants]
     
United States   7   5   12 
Baseline edema measure [1] 
[Units: Cm^3]
Mean (Standard Deviation)
 10.8  (11.1)   11.3  (8.1)   11.1  (9.4) 
[1] Baseline measure was acquired for 11 patients. Six on Arm I and five on Arm II.


  Outcome Measures

1.  Primary:   Change From Pooled Baseline in Peritumoral Brain Edema   [ Time Frame: at 2 months ]

2.  Primary:   Change From Baseline in Peritumoral Brain Edema   [ Time Frame: at 4 months ]

3.  Primary:   Change From Baseline in Peritumoral Brain Edema   [ Time Frame: at 6 months ]

4.  Secondary:   Quality of Life at 6 Months   [ Time Frame: At 2, 4, 6, 12, and 24 months ]

5.  Secondary:   Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 6 Months   [ Time Frame: 6 months ]

6.  Secondary:   Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 1 Year   [ Time Frame: 1 year ]

7.  Secondary:   Overall Survival: Percentage of Patients That Were Alive at 1 Year   [ Time Frame: 1 year. ]

8.  Secondary:   Food Intake as Assessed by the Block 98 Food Frequency Questionnaire and a 3-day Food Record   [ Time Frame: At 2, 4, 6, 12, and 24 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Certain outcome analysis not done due to low patient accrual.


  More Information

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
e-mail: steveng@ccf.org



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