Clinical trial NCT00243022: Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
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
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-10-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Pooled Baseline in Peritumoral Brain Edema
timeFrame: at 2 months
measure: Change From Baseline in Peritumoral Brain Edema
timeFrame: at 4 months
measure: Change From Baseline in Peritumoral Brain Edema
timeFrame: at 6 months
Secondary outcomes:
measure: Quality of Life at 6 Months
timeFrame: At 2, 4, 6, 12, and 24 months
measure: Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 6 Months
timeFrame: 6 months
measure: Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 1 Year
timeFrame: 1 year
measure: Overall Survival: Percentage of Patients That Were Alive at 1 Year
timeFrame: 1 year.
Other outcomes:
measure: Food Intake as Assessed by the Block 98 Food Frequency Questionnaire and a 3-day Food Record
timeFrame: At 2, 4, 6, 12, and 24 months
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Glen Stevens, DO, PhD
role: PRINCIPAL_INVESTIGATOR
References: