Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme

What Was Tested

The trial (phase 2) is built around Cyanocobalamin (Vitamin B12).

RATIONALE: Giving the herb Boswellia serrata after surgery and radiation therapy may slow the growth of any remaining tumor cells.

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).

It had two arms (groups): Arm I (intervention) (experimental) and Arm II (control) (active comparator).

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.

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

The registry classes the interventions as dietary supplement and drug.

More on the Plan

OUTLINE: This a randomized, controlled study.

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.

Who Took Part

12 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 9 inclusion and 6 exclusion criteria; among the exclusions: any medical condition that could interfere with eating and oral administration of b. serrata; patients already taking herbal preparations that contain 5-lo inhibitors; pregnancy and breastfeeding.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

Everyone knew when Cyanocobalamin (Vitamin B12) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2004-09 with completion listed for 2010-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Pooled Baseline in Peritumoral Brain Edema (time frame: at 2 months). Change From Baseline in Peritumoral Brain Edema (time frame: at 4 months). Change From Baseline in Peritumoral Brain Edema (time frame: at 6 months).

It also tracked 4 secondary outcomes, for example Quality of Life at 6 Months, Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 6 Months, Time-to-tumor-progression: Percentage of Patients With Tumor Progression at 1 Year and Overall Survival: Percentage of Patients That Were Alive at 1 Year.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cyanocobalamin (Vitamin B12) in 12 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.