Researchers at the University of California San Francisco are recruiting patients for the first study in the U.S. that will determine the feasibility of using Chinese herbal therapy to alleviate the side effects of chemotherapy in women with early stage breast cancer.
Developed in collaboration at UCSF with Western breast cancer investigators and practitioners as well as non-Western herbalists, this study aims to scientifically evaluate the benefits of a Chinese herbal formula that is widely used by herbalists for cancer patients receiving chemotherapy. In addition, the trial will assess any toxicities associated with the use of the formula in conjunction with chemotherapy.
After conferring with many herbalists around the world, studying past clinical trials of herbal therapies, and reading text books on the subject, UCSF researchers developed a formula consisting of a range of herbs that they hope will alleviate multiple side effects of chemotherapy. The formula contains 21 herbs and has received an Investigational New Drug (IND) license from the Food and Drug Administration which is necessary to conduct a clinical trial.
This novel trial is a crucial first step to integrating traditional Chinese medicine, where effective, into the standard of care for breast cancer patients, UCSF researchers said.
"Ultimately, we would like to develop a model in which we integrate the parts of herbal therapies that are safe and effective with those that we know are effective in standard conventional therapy, such as chemotherapy," said Debu Tripathy, MD, UCSF associate professor of medicine, director of clinical research at the UCSF Carol Franc Buck Breast Care Center and principal investigator of the study.
In the U.S., most women are diagnosed with breast cancer at an early stage. Chemotherapy is being recommended more often as studies now show a clear reduction in the risk of cancer spread, Tripathy said. However, he added that the treatment is often accompanied by side effects including fatigue, nausea, vomiting, lowered white blood cell counts, hair loss, psychological distress and a decrease in quality of life.
In the San Francisco Bay area alone, it is estimated that 64 percent of women with breast cancer use at least one type of complementary therapy to reduce the side effects of Western treatment or improve their quality of life. Tripathy said that, because so many of his patients use alternative therapies, he feels it is his duty and responsibility to learn more about such treatments by scientifically evaluating them in clinical trials.
He designed a study that will provide breast cancer patients access to herbal therapy who typically would not receive a prescription for this treatment from their oncologists.
However, in order for the trial to be effective, he said, participants will be randomized to receive either the herbal formula or a placebo so that researchers can discern which side effects, if any, are caused by the herbal therapy versus chemotherapy. In addition, this will enable researchers to get a better approximation of the herbal therapy's benefits in terms of a patient's lowered side effects.
It is a double-blind study, meaning that neither the patient nor the doctor will know who is receiving the herbal treatment or placebo. All participants will receive standard (non-herbal) supportive treatments for side effects of chemotherapy, including anti-nausea and pain medications. Women who are eligible for the study must be about to receive the commonly used regimen of Adriamycin and Cytoxan (AC) chemotherapy and have Stage I or Stage II breast cancer. Participants will begin taking the Chinese herbal formula two weeks before their first chemotherapy session. It comes in powder form, and is mixed with warm water to be taken like a tea. Each patient's progress will be followed closely over a 180-day period by a research team including a medical oncologist, epidemiologist, and licensed herbalist/acupuncturist. Patients will also complete questionnaires throughout the study regarding their overall health, sense of well being, and experience with the herbal formula. The study will run for approximately 12-18 months and involves 60 women. The Arkay Foundation, a non-profit organization interested in women's health and alternative therapies, helped to fund the clinical trial. It has been approved by UCSF's Cancer Center Scientific Protocol Review Committee and the Committee of Human Research.
For more information or to participate in the study, please call Erika Leemann at (415) 885-7328 or by email at erika_leeman@quickmail.ucsf.edu