Suspended

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

What is being tested

Boswellia serrata extract

+ cyanocobalamin

DrugDietary Supplement

Who is being recruted

Astrocytoma+16

+ Brain Diseases

+ Brain Edema

Over 18 Years

+15 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: September 2004

See protocol details

Summary

Principal SponsorAli Altunkaya

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitlePhase 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

NCT00243022

Principal SponsorAli Altunkaya

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AstrocytomaBrain DiseasesBrain EdemaCentral Nervous System DiseasesGlioblastomaGliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNervous System DiseasesNervous System NeoplasmsOligodendrogliomaCentral Nervous System NeoplasmsNeuroectodermal TumorsNeoplasms, NeuroepithelialGliosarcoma

Criteria

9 inclusion criteria required to participate

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

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6 exclusion criteria prevent from participating

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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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.

Group II

Active Comparator

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, United StatesOpen Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center in Google Maps

SuspendedOne Study Center