Brain and Central Nervous System TumorsPhase 2NCT00243022

Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme

A Phase 2 study testing Boswellia serrata extract and cyanocobalamin in people with Brain and Central Nervous System Tumors and Cerebral Edema, run by Ali Altunkaya at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Brain and Central Nervous System Tumors, Cerebral Edema
What is being tested?: Boswellia serrata extract and cyanocobalamin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Sep 2004to Mar 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients after surgical removal of histologically confirmed World Health Organization high-grade gliomas, including astrocytomas grade III (anaplastic astrocytoma), astrocytoma grade IV (glioblastoma multiforme, GBM), anaplastic oligodendroglioma and oligoastrocytoma
Karnofsky performance status of greater or equal 60
Patients who signed informed consent
Patients can be receiving standard or investigational chemotherapy , hormonal therapy, immunotherapy or biologic agents as the primary treatment for their tumor
Glucocorticoid therapy is allowed
Bone marrow function (absolute neutrophil count [ANC] >=1500/mm^3 and platelet count >=75,000/mm^3); in the event of plate count dropping below 50,000/ mm^3 the Boswellia will be withdrawn until plate count reaches 75,000 mm^3 and above

Show all 9Show fewer

Liver function (bilirubin and alkaline phosphatase =< 2 x normal and serum glutamic oxaloacetic transaminase [SGOT] =< 3 x normal)
Renal function (blood urea nitrogen [BUN] or creatinine =< 1.5 x normal)
Patients suffering from mild to moderate asthma, liver and kidney disease; an assessment of the condition will be made to establish a baseline and monitor progress at 4 weekly intervals to start with for the first two months and thereafter at the usual study intervals of 4 and 6 months; if there is any significant deterioration in their condition the Boswellia will be withdrawn until these parameters are restored to their pre-treatment levels

Who cannot join

Any medical condition that could interfere with eating and oral administration of B. serrata
Patients already taking herbal preparations that contain 5-LO inhibitors
Any previous (within the past 3 years) or concurrent malignancies at other sites, with the exception of surgically cured carcinoma-in-situ of the cervix and non-melanoma skin cancer
Pregnancy and breastfeeding
Active infection
Inability to be followed closely at the Cleveland Clinic Foundation

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Phase II Randomized Evaluation of 5-Lipoxygenase Inhibition by Herbal Complementary and Alternative Medicine Approach Compared to Control as an Adjuvant Therapy in Newly Diagnosed and Recurrent 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.

Read the detailed description

OBJECTIVES:

Primary

To determine whether a herbal approach to decreasing 5-LO eicosanoid production reduces peritumoral brain edema in patients with HGG.

Secondary

To determine if this adjuvant approach improves the quality of life and progression free and overall survival of patients with HGG.

OUTLINE: This a randomized, controlled study. Patients are randomized to 1 of 2 treatment arms.

Arm I (intervention): Patients receive oral Boswellia serrata herbal 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): Patients receive oral vitamin B-12 once a day for 6 months. All patients are encouraged to eat a regular balanced diet (as recommended by the American Cancer Society for cancer prevention) with limited consumption of red and processed meats.

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.

Conditions: Brain and Central Nervous System Tumors, Cerebral Edema
Being tested: Boswellia serrata extract, cyanocobalamin
Keywords: cerebral edema, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma
Medical subject headings: Central Nervous System Neoplasms, Brain Edema, Glioblastoma, Gliosarcoma, Astrocytoma, Oligodendroglioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Boswellia serrata extractDrug
given orally
cyanocobalaminDietary supplement
Also called Vitamin B12
given orally

Study groups in NCT00243022
Study group	Role	What they receive
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. Receives: Drug: Boswellia serrata extract; Dietary Supplement: cyanocobalamin
Arm II (control)	Active comparator	Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months. Receives: Dietary Supplement: cyanocobalamin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 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.
Measured: at 6 months

Secondary outcomes (4)

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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2004Mar 2011

First posted21 Oct 2005 (estimated)
Study startSep 2004
Primary completionMar 2010
Study completionMar 2011

Why it stopped: Slow accrual

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00243022
Sponsor's protocol ID: CASE1304
Other IDs: CCF-7348, NCI-2010-01384, R21CA107277-01
Status last verified: Apr 2019
First submitted: 20 Oct 2005
Last updated: 30 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Recruiting
Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors
Cancer-related Cognitive Dysfunction, Primary Brain Neoplasm

All Brain and Central Nervous System Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Randomized Evaluation of 5-Lipoxygenase Inhibition by Herbal Complementary and Alternative Medicine Approach Compared to Control as an Adjuvant Therapy in Newly Diagnosed and Recurrent High-grade Gliomas
ClinicalTrials.gov ID: NCT00243022
Acronym / sponsor ID: CASE1304
Conditions: Brain and Central Nervous System Tumors, Cerebral Edema
Keywords: cerebral edema, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow accrual
Enrolment: 12 participants (actual)
Lead sponsor: Ali AltunkayaUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Sep 2004
Primary completion: Mar 2010 (actual)
Study completion: Mar 2011 (actual)
First posted: 21 Oct 2005 (estimated)
Results: Posted 30 Jul 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

OBJECTIVES:

Primary

To determine whether a herbal approach to decreasing 5-LO eicosanoid production reduces peritumoral brain edema in patients with HGG.

Secondary

To determine if this adjuvant approach improves the quality of life and progression free and overall survival of patients with HGG.

OUTLINE: This a randomized, controlled study. Patients are randomized to 1 of 2 treatment arms.

Arm I (intervention): Patients receive oral Boswellia serrata herbal 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): Patients receive oral vitamin B-12 once a day for 6 months. All patients are encouraged to eat a regular balanced diet (as recommended by the American Cancer Society for cancer prevention) with limited consumption of red and processed meats.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm I (intervention)	Experimental	Drug: Boswellia serrata extract, Dietary Supplement: cyanocobalaminPatients 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	Dietary Supplement: cyanocobalaminPatients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Patients after surgical removal of histologically confirmed World Health Organization high-grade gliomas, including astrocytomas grade III (anaplastic astrocytoma), astrocytoma grade IV (glioblastoma multiforme, GBM), anaplastic oligodendroglioma and oligoastrocytoma
Karnofsky performance status of greater or equal 60
Patients who signed informed consent
Patients can be receiving standard or investigational chemotherapy , hormonal therapy, immunotherapy or biologic agents as the primary treatment for their tumor
Glucocorticoid therapy is allowed

Key exclusion criteria (6 listed)

Any medical condition that could interfere with eating and oral administration of B. serrata
Patients already taking herbal preparations that contain 5-LO inhibitors
Any previous (within the past 3 years) or concurrent malignancies at other sites, with the exception of surgically cured carcinoma-in-situ of the cervix and non-melanoma skin cancer
Pregnancy and breastfeeding
Active infection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Boswellia serrata extractgiven orally	Drug	Arm I (intervention)
cyanocobalaminAlso: Vitamin B12given orally	Dietary supplement	Arm I (intervention), Arm II (control)

Primary outcome

Change From Pooled Baseline in Peritumoral Brain Edema
Time frame: at 2 months
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
Change From Baseline in Peritumoral Brain Edema
Time frame: at 4 months
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.
Change From Baseline in Peritumoral Brain Edema
Time frame: at 6 months
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.

4 secondary outcomes

Quality of Life at 6 Months
Time frame: At 2, 4, 6, 12, and 24 months
Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 6 Months
Time frame: 6 months
Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 1 Year
Time frame: 1 year
Overall Survival: Percentage of Patients That Were Alive at 1 Year
Time frame: 1 year.

Results and safety

Results posted to the registry on 30 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm I (Intervention)	7	5
Arm II (Control)	5	4

Primary outcome: Change From Pooled Baseline in Peritumoral Brain Edema

Time frame: at 2 months. Mean (Standard Deviation). Unit: cm^3

Measure	Arm I (Intervention) n = 4	Arm II (Control) n = 2
Value	-3.87 (8.0)	-3.045 (2.14)

Arm I (Intervention) vs Arm II (Control): p = 0.9, t-test, 2 sided

Population analysed: 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.

Primary outcome: Change From Baseline in Peritumoral Brain Edema

Time frame: at 4 months. Mean (Standard Deviation). Unit: cm^3

Measure	Arm I (Intervention) n = 5	Arm II (Control) n = 4
Value	-2.7 (7.3)	10.21 (14.06)

Arm I (Intervention) vs Arm II (Control): p = 0.12, t-test, 2 sided

Population analysed: 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.

Primary outcome: Change From Baseline in Peritumoral Brain Edema

Time frame: at 6 months. Mean (Standard Deviation). Unit: cm^3

Measure	Arm I (Intervention) n = 2	Arm II (Control) n = 2
Value	-3.7 (9.5)	-1.5 (2.9)

Arm I (Intervention) vs Arm II (Control): p = 0.8, t-test, 2 sided

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected over a 4 year period while patients were on treatment. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm I (Intervention)	0 of 7 (0%)	3 of 7 (42.9%)	Not reported
Arm II (Control)	2 of 5 (40%)	3 of 5 (60%)	Not reported

Limitations and caveats (from the sponsor): Certain outcome analysis not done due to low patient accrual.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Brain and Central Nervous System Tumors

RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Recruiting
Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors
Cancer-related Cognitive Dysfunction, Primary Brain Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Glen Stevens, DO, PhD principal investigator

The Cleveland Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Boswellia serrata extract and cyanocobalamin in people with Brain and Central Nervous System Tumors and Cerebral Edema, run by Ali Altunkaya at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Pooled Baseline in Peritumoral Brain Edema (time frame: at 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00243022.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.