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

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What is this study about?

This clinical trial is focused on studying the treatment of superficial bladder cancer, a type of cancer that affects the bladder’s inner lining. The study involves two treatments: abnobaVISCUM Fraxini, which is an extract from fresh ash mistletoe herb, and Mitomycin, a cytotoxic antibiotic. The purpose of the study is to compare the effectiveness of abnobaVISCUM Fraxini with Mitomycin in preventing the recurrence of bladder cancer.

Participants in the study will receive the treatment directly into the bladder, a method known as intravesical use. The study will monitor how long it takes for the cancer to return, if it does, and will also assess the safety and tolerability of the treatments. This includes checking for any side effects and evaluating the overall health and quality of life of the participants.

The study will last for a period of up to 48 weeks, during which participants will be closely observed. The main goal is to determine which treatment is more effective in delaying the return of the cancer. Additionally, the study will gather information on the safety of the treatments, including any potential side effects, to ensure that they are well-tolerated by patients.

1 initial consent and eligibility

Upon joining the study, a signed and dated written informed consent is required. This confirms understanding of the study and agreement to participate.

Eligibility is confirmed based on age (18 to 85 years), health status, and specific medical history related to bladder cancer.

2 baseline assessments

Initial assessments include checking overall health, including kidney and liver function, heart health, and blood tests.

For female participants of childbearing potential, a pregnancy test is conducted.

3 treatment administration

The treatment involves the administration of mistletoe extract directly into the bladder. This is known as intravesical use.

The alternative treatment is mitomycin, also administered intravesically. The specific dosage and frequency are determined by the study protocol.

4 monitoring and follow-up

Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes checking for any side effects and conducting laboratory tests.

The primary focus is on the time to any recurrence of the bladder tumor. If a recurrence is detected, the treatment is stopped.

5 end of study participation

Participation in the study concludes after the treatment period and follow-up assessments are completed.

The study aims to evaluate the long-term prognosis for recurrence and progression of bladder cancer, as well as the quality of life of participants.

Who Can Join the Study?

  • Must provide a signed and dated written consent to participate in the study and agree to follow the study rules.
  • Can be either male or female and must be an outpatient (not staying in the hospital).
  • Must be aged between 18 to 85 years.
  • Must have had a completely removed superficial bladder cancer (Stage Ta) classified as intermediate-risk, with a specific treatment given right after surgery.
  • Must have a Karnofsky Performance Status between 50% to 100%, which means the ability to carry out normal activities or at least take care of oneself with some help.
  • Must have a life expectancy of at least 2 years.
  • Must have normal kidney, liver, heart, and blood function. Slightly abnormal lab results may be acceptable if not considered significant by the doctor.
  • Female patients who can have children must have a negative pregnancy test before starting the study. They must also meet one of the following conditions:
    • Be post-menopausal, meaning no menstrual periods for at least 12 months without hormone treatments, and have hormone levels in the post-menopausal range.
    • Have had irreversible surgical sterilization, such as removal of the uterus or ovaries, but not just having the fallopian tubes tied.
    • If sexually active, must use an effective method of birth control from the time of consent until 12 weeks after the last treatment.

Who Cannot Join the Study?

  • Patients who are younger than 18 years or older than 85 years.
  • Patients who have not had a complete removal of their superficial bladder cancer.
  • Patients with a type of bladder cancer that is not classified as intermediate-risk according to the European Association of Urology (EAU).
  • Patients who have a type of bladder cancer called CIS (carcinoma in situ) or G3 tumors (grade 3 tumors, which are more aggressive).
  • Patients who have not undergone a procedure called TURB (transurethral resection of the bladder), which is a surgery to remove bladder tumors.
  • Patients who have not received one dose of chemotherapy directly into the bladder with either MMC (Mitomycin C) or epirubicin right after surgery.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Urologie Heinsberg Heinsberg Germany
Urologische Praxis Herzberg Herzberg am Harz Germany
Ujdotmoqwoh Pjddso aq Wehivekfwq Würselen Germany
Uglxkhbmsephiqufhqyvx Epgmn Art Essen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
27.03.2015

Trial locations

Investigated drugs:

abnobaVISCUM® 900 is a therapy derived from mistletoe extract. It is used in this clinical trial to treat patients with superficial bladder cancer. The goal of using this therapy is to see if it can help prevent the cancer from coming back after treatment. Mistletoe extract has been studied for its potential to boost the immune system and fight cancer cells, and this trial aims to compare its effectiveness against a standard treatment.

Mitomycin C is a standard chemotherapy drug used to treat bladder cancer. It works by stopping the growth of cancer cells, which can help prevent the cancer from returning. In this trial, Mitomycin C is used as a comparison to see how well the mistletoe extract therapy works in preventing tumor recurrence in patients with superficial bladder cancer.

Superficial Bladder Carcinoma – Superficial bladder carcinoma is a type of cancer that occurs in the bladder’s inner lining. It is characterized by the presence of tumors that have not invaded the muscle layer of the bladder. The disease often begins with the formation of small, non-invasive tumors known as papillary tumors. These tumors can vary in size and number and may recur after treatment. The progression of superficial bladder carcinoma is typically slow, but it can lead to more aggressive forms if not monitored. Regular follow-up is essential to detect any changes in the tumor’s behavior.

Trial ID:
2023-503718-66-00
Protocol code:
Study-AB03
NCT ID:
NCT02106572
Trial Phase:
Therapeutic confirmatory (Phase III)

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