Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme

This study has been terminated.
(Slow accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ali Altunkaya, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00243022
First received: October 20, 2005
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Cerebral Edema
Drug: Boswellia serrata extract
Dietary Supplement: cyanocobalamin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Change From Pooled Baseline in Peritumoral Brain Edema [ Time Frame: at 2 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Quality of Life at 6 Months [ Time Frame: At 2, 4, 6, 12, and 24 months ] [ Designated as safety issue: No ]
    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)

  • Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 1 Year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Overall Survival: Percentage of Patients That Were Alive at 1 Year [ Time Frame: 1 year. ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    The 3-day food diary will be used to assess the dietary intake and to increase eating awareness of patients.


Enrollment: 12
Study Start Date: September 2004
Study Completion Date: March 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Boswellia serrata extract
given orally
Dietary Supplement: cyanocobalamin
given orally
Other Name: Vitamin B12
Active Comparator: Arm II (control)
Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.
Dietary Supplement: cyanocobalamin
given orally
Other Name: Vitamin B12

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243022

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Ali Altunkaya
Investigators
Principal Investigator: Glen Stevens, DO, PhD The Cleveland Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Ali Altunkaya, Principal Investigator, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00243022     History of Changes
Other Study ID Numbers: CASE1304, CCF-7348, NCI-2010-01384, R21CA107277-01
Study First Received: October 20, 2005
Results First Received: October 11, 2012
Last Updated: June 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Case Comprehensive Cancer Center:
cerebral edema
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma

Additional relevant MeSH terms:
Brain Edema
Edema
Glioblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Hydroxocobalamin
Vitamin B 12
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014