Boswellia Serrata and Standard Treatment or Standard Treatment Alone in Treating Patients Who Have Undergone Surgery and Radiation Therapy for Newly Diagnosed or Recurrent High-Grade Glioma - Full Text View

Sponsor:	The Cleveland Clinic
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00243022

Purpose

RATIONALE: Giving the herbBoswellia 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 studying Boswellia serrata and standard treatment to see how well it works compared to standard treatment alone in treating patients who have undergone surgery and radiation therapy for newly diagnosed or recurrent high-grade gliomas.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	Phase II Randomized Evaluation of 5-Lipoxygenase Inhibition by Herbal Medicine Approach Compared to Control as an Adjuvant Therapy in Newly Diagnosed and Recurrent High-Grade Gliomas

Resource links provided by NLM:

MedlinePlus related topics: B Vitamins Cancer Edema

Drug Information available for: Vitamin B 12 Hydroxocobalamin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Efficacy of a selective anti-inflammatory herbal regimen in reducing peritumoral brain edema at 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life at 6 months [ Designated as safety issue: No ]
Progression-free survival at 6 months [ Designated as safety issue: No ]
Overall survival at 6 months [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	August 2005
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Dietary Supplement: Boswellia serrata extract given orally Dietary Supplement: cyanocobalamin given orally
Active Comparator: Arm II (control) Patients receive oral vitamin B 12 once a day for 6 months.	Dietary Supplement: cyanocobalamin given orally

Detailed Description:

OBJECTIVES:

Primary

Compare the efficacy of addition of adjuvant Boswellia serrata, a selective anti-inflammatory herbal medicine, to standard treatment vs standard treatment alone in reducing tumor growth and peritumoral brain edema in patients with newly diagnosed or recurrent high-grade gliomas.

Secondary

Compare the progression-free and overall survival of patients treated with these regimens.
Compare the quality of life of patients treated with these regimens.
Compare the use of steroids between the two groups.

OUTLINE: This a randomized, controlled study. Patients are stratified according to age (< 65 years vs > 65 years) and Karnofsky performance status (70-80% vs 90-100%). 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

DISEASE CHARACTERISTICS:

Histologically confirmed high-grade glioma of 1 of the following types:
- Grade III astrocytoma (anaplastic astrocytoma)
- Grade IV astrocytoma (glioblastoma multiforme)
- Anaplastic oligodendroglioma
- Oligoastrocytoma
Newly diagnosed or recurrent disease
Had undergone prior surgical resection followed by post-surgical radiotherapy

PATIENT CHARACTERISTICS:

Performance status

Karnofsky 70-100%

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3

Hepatic

Bilirubin ≤ 2 times normal
Alkaline phosphatase ≤ 2 times normal
SGOT ≤ 3 times normal
No liver disease

Renal

BUN ≤ 1.5 times normal
Creatinine ≤ 1.5 times normal
No kidney disease

Pulmonary

No asthma

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No medical condition that would interfere with eating and oral administration of study drug
No active infection
No other malignancy within the past 3 years except surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

Concurrent standard or investigational immunotherapy or biologic agents as primary treatment for brain tumor allowed

Chemotherapy

Concurrent standard or investigational chemotherapy as primary treatment for brain tumor allowed

Endocrine therapy

Concurrent glucocorticoid therapy allowed
Concurrent standard or investigational hormonal therapy as primary treatment for brain tumor allowed

Radiotherapy

See Disease Characteristics

Surgery

See Disease Characteristics

Other

No other concurrent herbal preparations containing 5-lipoxygenase inhibitors, including any of the following:
- Boswellia serrata
- H 15 Ayurmedica sallaki
- Boswellia extract
- Boswellin
- Boswellia resin extract
- Ayur-Boswellia serrata
- Boswellia extract
- Boswellia
- Boswellia serrata standardized extract
- Weihrauch
- Boswellia with ascorbic acid (vitamin C)
- Cyclooxygenase-2 (COX-2) combo
- COX-2-IH plus
- Methylsulfonylmethane (MSM) with Boswellia
- MSM
- BotanoDyne
- Melatonin
- Hypericum perforatum (St. John's wort)
- Curcumin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243022

Locations

United States, Ohio
Cleveland Clinic Taussig Cancer Center	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100

Sponsors and Collaborators

The Cleveland Clinic

National Cancer Institute (NCI)

Investigators

Study Chair:

Glen H. J. Stevens, DO, PhD

The Cleveland Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Featured trial article This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Glen H. J. Stevens, Cleveland Clinic Taussig Cancer Center
ClinicalTrials.gov Identifier:	NCT00243022 History of Changes
Other Study ID Numbers:	CDR0000445603, CASE-CCF-7348, CCF-7348
Study First Received:	October 20, 2005
Last Updated:	May 9, 2009
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

cerebral edema
adult glioblastoma
adult giant cell glioblastoma

adult gliosarcoma
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma

Additional relevant MeSH terms:

Brain Edema
Edema
Nervous System Neoplasms
Central Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms
Neoplasms by Site
Neoplasms
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 February 21, 2012