Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme
This study is ongoing, but not recruiting participants.
Sponsor:
Case Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00243022
First received: October 20, 2005
Last updated: September 19, 2012
Last verified: September 2012
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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 like in patients with HGG.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Cerebral Edema |
Dietary Supplement: 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 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.
- 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.
- 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.
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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]Time-to-tumor-progression will be measured from enrollment to documented progression or death, which ever comes first.
- Time-to-tumor-progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]Time-to-tumor-progression will be measured from enrollment to documented progression or death, which ever comes first.
- Overall Survival [ 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 |
| Estimated Primary Completion Date: | January 2013 (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.
|
Dietary Supplement: 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
Case Comprehensive Cancer Center
Investigators
| Principal Investigator: | Glen Stevens, DO, PhD | The Cleveland Clinic |
More Information
Additional Information:
No publications provided
| Responsible Party: | 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 |
| Last Updated: | September 19, 2012 |
| 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 May 21, 2013