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Extract Of Fresh Ash Mistletoe Herb

This article discusses a Phase III clinical trial investigating the use of Extract of Fresh Ash Mistletoe Herb (abnobaVISCUM®) in treating superficial bladder cancer. The study aims to compare the efficacy and safety of this innovative treatment with the standard Mitomycin C therapy. Researchers are particularly interested in examining the time to tumor recurrence and the overall safety profile of the mistletoe extract when administered directly into the bladder.

Table of Contents

Overview of the Treatment

The EXTRACT OF FRESH ASH MISTLETOE HERB is being studied as a potential treatment for superficial bladder cancer. This extract is derived from mistletoe plants that grow on ash trees and is being investigated under the brand name abnobaVISCUM® 900[1]. The treatment is administered directly into the bladder, a method known as intravesical instillation.

Medical Condition Treated

This treatment is being studied for patients with superficial bladder cancer, specifically those with:

  • Stage Ta tumors (tumors confined to the inner lining of the bladder)
  • Intermediate-risk classification according to the European Association of Urology (EAU)
  • No presence of carcinoma in situ (CIS) or G3 (high-grade) tumors
Patients must have undergone complete tumor removal through a procedure called transurethral resection of bladder tumor (TURB) and received one post-operative intravesical instillation of either Mitomycin C or Epirubicin[1].

Study Objectives

The main goals of the study are:

  1. To assess how effective abnobaVISCUM® 900 is compared to Mitomycin C (MMC) in treating superficial bladder cancer. The primary measure of effectiveness is the time it takes for the tumor to recur[1].
  2. To evaluate the safety of abnobaVISCUM® 900 compared to MMC, focusing on side effects and how well patients tolerate the treatment[1].
  3. To assess other factors such as the likelihood of cancer recurrence or progression after one year, tumor grading, and the patient’s quality of life[1].

Eligibility Criteria

To participate in this study, patients must meet certain criteria, including:

  • Age between 18 and 85 years
  • Completely resected superficial bladder cancer (Stage Ta)
  • Intermediate-risk classification
  • Adequate overall health status (Karnofsky Performance Status of 50% to 100%)
  • Life expectancy of at least 2 years
  • Normal kidney and liver function
There are also several conditions that would exclude a patient from participating, such as having advanced bladder cancer, certain other medical conditions, or previous treatments that might interfere with the study[1].

Treatment Details

The study is designed as follows:

  1. A 6-week screening period to determine eligibility
  2. A 48-week treatment period where patients receive either abnobaVISCUM® 900 or Mitomycin C
  3. A 48-week follow-up period to monitor long-term effects
The mistletoe extract (abnobaVISCUM® 900) is administered as a solution for injection directly into the bladder. The maximum daily dose is 45 ml, with a total maximum dose of 675 ml over the treatment period[1].

Effectiveness Measures

The main measure of how well the treatment works is the time to tumor recurrence. This means how long it takes for the cancer to come back after treatment. Other measures include:

  • The estimated risk of cancer recurrence and progression after one year
  • Changes in tumor grading (how abnormal the cancer cells look under a microscope)
  • The patient’s quality of life, measured using specific questionnaires (EORTC QLQ-C30 and BLS24)[1]

Safety and Side Effects

The study closely monitors the safety of the treatment by:

  • Tracking any adverse events (side effects) using a standardized system called the Common Terminology Criteria for Adverse Events (CTCAE)
  • Performing regular laboratory tests to check blood counts, kidney and liver function
  • Assessing how well patients tolerate the treatment overall
Patients should be aware that there may be risks associated with the treatment, including potential allergic reactions to mistletoe products or the other ingredients in the medication[1].

Aspect Details
Study Type Phase III clinical trial
Primary Objective Assess efficacy of abnobaVISCUM® 900 vs. Mitomycin C in superficial bladder cancer
Primary Endpoint Time to tumor recurrence
Secondary Objectives Safety, toxicity, treatment efficacy, quality of life
Study Population Patients aged 18-85 with intermediate-risk superficial bladder cancer (Stage Ta)
Treatment Administration Intravesical instillation
Study Duration Approximately 2 years (6-week screening, 48-week treatment, 48-week follow-up)
Key Inclusion Criteria Completely resected superficial bladder cancer, intermediate-risk, post-TURB
Key Exclusion Criteria Advanced bladder cancer, hypersensitivity to study medications, recent experimental treatments

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this trial is to assess the effectiveness of abnobaVISCUM® 900 (Extract of Fresh Ash Mistletoe Herb) compared to Mitomycin C in treating superficial bladder cancer. The primary focus is on measuring the time to tumor recurrence.
  • Who can participate in this study? The study is open to male and female patients aged 18 to 85 years with completely resected superficial bladder cancer (Stage Ta tumors) classified as intermediate-risk. Participants must have undergone a TURB procedure and received one post-operative intravesical instillation of MMC or epirubicin.
  • How is the mistletoe extract administered in this trial? The Extract of Fresh Ash Mistletoe Herb (abnobaVISCUM®) is administered directly into the bladder, a method known as intravesical instillation. This allows the medication to directly target the affected area.
  • What are the secondary objectives of the study? Secondary objectives include evaluating the safety and toxicity of abnobaVISCUM® 900 compared to MMC, assessing treatment efficacy through recurrence and progression prognosis after one year, tumor grading, and measuring the patients' quality of life.
  • How long does the clinical trial last? The trial consists of a 6-week screening period, followed by a 48-week treatment period, and a 48-week follow-up period, totaling approximately two years for each participant.

Ongoing Clinical Trials on Extract Of Fresh Ash Mistletoe Herb

  • Study on the Effectiveness of Mistletoe Extract and Mitomycin in Patients with Superficial Bladder Cancer

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Germany

Glossary

  • Superficial bladder cancer: A type of bladder cancer that affects only the inner lining of the bladder and has not spread to deeper layers.
  • TURB: Transurethral Resection of Bladder Tumor, a surgical procedure to remove bladder tumors through the urethra.
  • Intravesical instillation: A method of administering medication directly into the bladder through a catheter.
  • Mitomycin C (MMC): A chemotherapy drug commonly used to treat superficial bladder cancer.
  • abnobaVISCUM®: A medicinal product containing Extract of Fresh Ash Mistletoe Herb, being studied as a potential treatment for superficial bladder cancer.
  • Phase III clinical trial: A large-scale study to confirm the effectiveness and safety of a new treatment compared to the current standard treatment.
  • Tumor recurrence: The return of cancer after treatment and a period of time when cancer was not detected.
  • Karnofsky Performance Status: A scale used to measure a patient's general well-being and activities of daily life.
  • EORTC: European Organization for Research and Treatment of Cancer, an organization that conducts, develops, coordinates, and stimulates cancer research in Europe.
  • Quality of Life (QoL): A measure of an individual's well-being, including physical, mental, and social aspects of their life, often assessed in clinical trials.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-mistletoe-extract-and-mitomycin-in-patients-with-superficial-bladder-cancer/