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Intravenous Mistletoe: Phase 1 Clinical Trial Complete!

Research Article Review by Kristina Gorden RN


With much anticipation, the first US study of mistletoe extract to treat cancer has been completed. This study was done in collaboration with Believe Big, a non-profit organization that helps bridge the gap between conventional and complementary medicine, and The John Hopkins School of Medicine. This phase 1 clinical trial was completed to determine the safety of intravenous mistletoe, specifically helixor M (apple tree mistletoe extract), and to determine the maximum tolerated dose (MTD), which would be tested further in the phase 2 clinical trial. In this study, 21 patients with advanced and treatment resistant solid tumors who had previously received at least one standard systemic therapy (ex. chemotherapy, immunotherapy, or hormone therapy), were given IV mistletoe three times a week on Monday, Wednesdays, and Fridays. The study took place between March 2017 and January 2021. They were given 4 different doses throughout the study: 150 mg, 300 mg, 600 mg, and 900 mg. This study measured tumor response, serum cytokines, tumor markers, and quality of life.


The study found that the maximum tolerated dose was 600 mg three times a week of helixor mali. One patient discontinued the study due to treatment related fatigue. The common side effects that the patients experienced were fatigue, nausea, and chills. They found that IV mistletoe had an overall manageable safety profile. The trial’s purpose was to evaluate the extract’s safety, but the researchers, led by Channing Paller, MD, associate professor of oncology, also documented improved quality of life and some disease control. Phase 2 clinical trials will be needed to better determine the optimal timing and dose frequency of IV mistletoe.


Although mistletoe therapy is not used frequently in the United States, it is commonly used in Germany for cancer treatment. Mistletoe can be used alongside chemotherapy, immunotherapy, and radiation to help lessen the side effects of these therapies, and to increase a patient’s quality of life. This study is important as it helps to demonstrate the safety of IV mistletoe. As the study progresses in phases, it could lead to FDA approval which would then lead to greater access of IV mistletoe for patients and better acceptance of the treatment by conventional oncologists. Dr. Puc, founder and physician owner of IM of CNY, is trained in mistletoe therapy and recommends IV mistletoe for some of her patients that are being treated for cancer. IV mistletoe is administered in our office over a 3-hour period. Typically, this treatment is generally well tolerated but side effects such as fever, rash, nausea, and flu-like symptoms can occur. One of the benefits of IV mistletoe is that one can administer higher doses of mistletoe than is feasible with subcutaneous injections. This can allow for a quicker response and possibly a more aggressive treatment regimen. Dr. Puc will determine which type of mistletoe is best for the patient based on type of cancer. For more information on IV mistletoe and if you are interested in becoming a patient of Integrative Medicine of CNY, please contact us at (315)741-5774. For more information on the phase 1 clinical trial, please visit https://www.believebig.org/.


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