Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme

Ali Altunkaya

Status and phase: Terminated; Phase 2

Conditions: Cerebral Edema; Brain and Central Nervous System Tumors

Treatments: Drug: Boswellia serrata extract; Dietary Supplement: cyanocobalamin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00243022

NCI-2010-01384 (Other Identifier)

R21CA107277-01 (U.S. NIH Grant/Contract)

CCF-7348 (Other Identifier)

CASE1304

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Arm I (intervention)

Experimental 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.

Treatment:

Dietary Supplement: cyanocobalamin

Drug: Boswellia serrata extract

Arm II (control)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: cyanocobalamin