Johns Hopkins Kimmel Cancer Center Completed Phase I Trial of Intravenous Mistletoe

Non-profit Believe Big funded research shows mistletoe treatment safe and improves quality of life for cancer patients.

Hunt Valley, Maryland — February 23, 2023 — The first mistletoe therapy clinical trial in the United States utilizing intravenous Mistletoe has been completed by oncologists at the Johns Hopkins Kimmel Cancer Center. Spearheaded by Believe Big, a non-profit cancer assistance organization founded by cancer survivor and mistletoe advocate Ivelisse Page, the Phase I trial began in 2015 with the goal of evaluating the safety of Mistletoe use for cancer patients and determining the recommended dosing for Phase II.

In the trial, Helixor M Mistletoe was administered intravenously three times a week to 21 participants. The results indicate improvement in quality of life.

Trial results were published in February 2023 by the American Association for Cancer Research.

Download the Mistletoe clinical trial results here >


Mistletoe Prescribed Widely in Europe

Mistletoe, one of the most widely studied CAM (Complementary and Alternative Medicine) therapies for cancer treatment, has been in common use in Europe for over a century, using extracts of the mistletoe plant. According to the National Cancer Institute, preparations made from European mistletoe (Viscum album) are among the most prescribed drugs offered to cancer patients in some European countries. However, its use has not been widely explored in the United States, where almost 1 in 2 people will be diagnosed with cancer in their lifetime.

Although Mistletoe is listed as an FDA approved substance in the homeopathic pharmacopeia and can be prescribed off label, oncologists cannot offer this treatment as standard of care in America until all phases of the trial are completed.

Currently, only the European species of the mistletoe plant is used for cancer treatment.  Mistletoe is one of the most prescribed complementary and/or alternative cancer treatments in Europe. Research in Germany finds it can reduce side-effects and toxicity during chemotherapy and radiotherapy, boost immune response, reduce pain, and increase survival times when used with orthodox medicine. Physicians in Europe are known to administer Mistletoe for treatment in malignant and non-malignant tumors to stimulate bone marrow activity alongside conventional treatments and to offset the side effects of chemotherapy/radiation such as nausea, vomiting, and lack of appetite. It can also be used to diminish tumor-related pain and to reduce the risk of tumor recurrence.

Since 1975, Helixor has been one of the leading international pharmaceutical companies in the field of integrative oncology and a respected manufacturer of various Mistletoe products used intravenously as well as for self-injections.


A Cancer Survivor’s Mistletoe Story

“We are at a monumental time in history that will be forever marked by the teamwork and belief by the team at Johns Hopkins, Believe Big supporters and the hand of God,” said Ivelisse Page, founder of Believe Big and a stage IV colon cancer survivor of 14 years. “I know how well mistletoe worked for me and my hope is that is becomes available to all patients.”

Page developed colon cancer at age 37, facing the same cancer that took her father’s life, her grandmother’s life, and half of her siblings. Discovering that the survivorship of stage IV colon cancer with metastasis to the liver was less than 8 percent, she made the decision to forgo chemotherapy and radiation, as it would not have increased her chances of survival. Instead, she pursued an integrative approach. After two surgeries, Page was monitored by her oncologist with scans and blood work and began her complementary treatments prescribed by her integrative physician which included mistletoe injections, a plant-based diet, homeopathy, cancer fighting supplements and more. She beat the 8 percent survival rate and has been cancer free since December 2008.


Additional Funding Needed for Phase II

Now that the maximum tolerated dose has been determined and its safety verified, it is possible to begin Phase II clinical trials, pending additional funding.

The road to a clinical trial is long, often arduous, and quite expensive. Traditionally in the United States, large pharmaceutical companies will spend hundreds of millions of dollars to begin the process and see a new drug through to a conclusion. Ivelisse Page and her Believe Big organization raised over $400,000 to kickstart this Mistletoe trial. Work has already begun to raise the funds needed for Phase II.

“This is an exciting development in the world of cancer treatment,” offers Page. “The more tools available in the medical arsenal, the more options the patient has. We are immensely grateful to the incredible staff at Johns Hopkins who have devoted their time and talents to this effort.  Our gratitude also goes to Helixor for making their Mistletoe products available for this study.”

About Believe Big

Established in 2011, Believe Big is a 501 (c) 3 non-profit founded by Ivelisse and Jimmy Page after her battle with Stage IV colon cancer. Believe Big serves those with cancer in the United States and beyond.  Believe Big offers a wide array of support mechanisms for cancer patients, ranging from nutrition therapy to Mistletoe education and patient advocacy. The organization helps cancer patients move through the overwhelming process of treatment by bridging the gap between conventional and complementary medicine to heal in all aspects of life: physically, emotionally, and spiritually.

To learn more, visit

For Immediate Release
Contact: Jeff Davis
410- 372-0827

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First U.S. Study of Mistletoe Extract to Treat Cancer – Johns Hopkins Kimmel Cancer Center – Press Release

First U.S. Study of Mistletoe Extract to Treat Cancer

Mistletoe extract has been widely used to support cancer therapy and improve quality of life, but questions remain due to a lack of clinical trials and data to support its use. Researchers at the Johns Hopkins Kimmel Cancer Center completed the first Phase I intravenous trial in the U.S. aimed at determining dosing for subsequent clinical trials and to evaluate safety.

The findings from the small study were reported online Feb. 9 in Cancer Research Communications.

The trial’s purpose was to evaluate the drug’s safety, but the researchers, led by Channing Paller, M.D., associate professor of oncology, also documented improved quality of life and some disease control.

The mistletoe extract (ME), known as Helixor M, was studied in 21 patients with advanced and treatment-resistant cancers of various types. The Phase I trial used dose escalation, exploring multiple dose levels delivered intravenously three times per week until disease progression or until toxicity. The study concluded the maximum tolerated dose to be 600 mg of ME.

The median follow-up duration on mistletoe was 15.3 weeks, however, the range among patients varied from two weeks to 101.1 weeks. Stable disease was observed in five patients and lasted, on average, for 15 weeks. Tumors in three participants decreased in size, and remained stable for two to five months, however, it did not meet official criteria for partial response. Patients also reported overall improved quality of life via a questionnaire. The most common side effects reported were fatigue, nausea, and chills and were manageable.

“Intravenous mistletoe demonstrated manageable toxicities with disease control and improved quality of life in this heavily pretreated group of patients,” says Paller, adding that additional Phase II studies in combination with chemotherapy are the next step, pending additional funding.

In addition, Paller says, laboratory research to better decipher ME’s mechanisms are needed, as the cytokines (cell-signaling proteins) measured in this study are preliminary and hypothesis generating.

Mistletoe extract is a semi-parasitic plant with several active ingredients that, in preclinical studies, appear to directly cause the death of tumor cells and stimulate an immune response. It has been used in Europe for several decades as a complementary medicine approach to cancer treatment alone or in combination with chemotherapy and radiation therapy but has not been evaluated in clinical trials. ME is not currently FDA approved for cancer treatment in the U.S. but is listed in the Homeopathic Pharmacopoeia and is offered in integrative care clinics.

In addition to Paller, other researchers included Lin Wang, Rajendra Kumar, Jennifer N. Durham, Nilofer S. Azad, Daniel A. Laheru, Ilene Browner, Sushant K. Kachhap, Kavya Boyapati, Thomas Odeny, Deborah K. Armstrong, Christian F. Meyer, Stephanie Gaillard, Julie R. Brahmer, Ivelisse Page, Hao Wang, and Luis A. Diaz

The research was supported by the National Institutes of Health P30CA006973, and Believe Big, Inc. Study drug was provided by Helixor Heilmittel GMBH.

To interview Dr. Paller about the study, email Amy Mone,, or Valerie Mehl,

Download the Mistletoe clinical trial results here >

Donate towards Phase II of the mistletoe clinical trial >

Link to original press release source >

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