Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme

NCT ID: NCT00243022

Last Updated: 2019-04-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2011-03-31

Brief 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.

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Boswellia serrata extract

Intervention Type: DRUG

given orally

cyanocobalamin

Intervention Type: DIETARY_SUPPLEMENT

given orally

Arm II (control)

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

Group Type: ACTIVE_COMPARATOR

cyanocobalamin

Intervention Type: DIETARY_SUPPLEMENT

given orally

Interventions

Boswellia serrata extract

given orally

Intervention Type: DRUG

cyanocobalamin

given orally

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Vitamin B12

Eligibility Criteria

Inclusion Criteria

• 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
• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Ali Altunkaya

OTHER

Sponsor Role: lead

Responsible Party

Ali Altunkaya

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Glen Stevens, DO, PhD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CCF-7348

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2010-01384

Identifier Type: OTHER

Identifier Source: secondary_id

R21CA107277-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE1304

Identifier Type: -

Identifier Source: org_study_id