Newsletter #57–Jan./Feb. 2000

Researchers at UCSF/Mt. Zion Launch Alternative Medicine Clinical Trials

by Edare K. Carroll

For years, breast cancer patients in the Bay Area have touted the effectiveness of integrating conventional Western medicine with alternative Eastern therapies. However, there has been little if any scientific data to support these claims, making alternative therapies difficult to come by in the mainstream health care market, All of that may be about to change now that new scientific research is under way at the University of California at San Francisco/Mt. Zion Breast Care Center.

The Center is running three alternative medicine clinical trials for women with breast cancer, under the direction of UCSF Cancer Center oncologist Debu Tripathy, M.D., and Isaac Cohen, L.Ac., O.M.D., from the American Acupuncture Center in Berkeley.

FDA Restrictions

To embark on any clinical trial, researchers must have an investigational new drug (IND) license. Since it was impossible for Cohen and Tripathy to get a license for every herb used in Chinese treatments, they were forced to compromise with a single comprehensive herbal formula.

"When you want to examine something within the Western medical profession, you have to follow the guidelines—that might fit the investigation of drugs but not necessarily the investigation of individualized biological modulators [the elements of the drugs], We imposed these restrictions in order to fit into this model, but it's less than ideal," Cohen explained.

Early-Stage Breast Cancer Trial

The first trial will test an herbal formula designed to alleviate symptoms and toxicities that result from chemotherapy. This double-blind, placebo-controlled trial of women diagnosed with earlystage breast cancer focuses on the adriamycin/cytoxan regimen, the most common chemotherapy suggested to women after surgery. The herbal formula is being evaluated for its ability to:

  • alleviate immediate side effects: nausea and vomiting, fatigue, abdominal discomfort or pain, constipation or diarrhea, and insomnia;
  • prevent toxicities from chemo: cardiac toxicities, bone marrow inhibition, and very mild bladder and hepatic toxicities;
  • activate, protect, restore, and modulate immune functions;
  • promote lymphocytic activity and function;
  • promote microcirculation.

"We believe that microcirculation helps both with the availability of the chemo and with aiding the body to get rid of the cellular debris and inflammation that result, due to cell death by necrosis," Cohen said. All the above functions are to be achieved without inhibiting, and possibly even enhancing, the chemotherapy effect.

"These are the goals we hope to achieve," Cohen added, "but since it is a pilot trial, we can't say yet that the herbs actually do that."

Recruitment Difficulty

Because each subject in the trial has a fifty-fifty chance of receiving the placebo, there has been some trouble with recruitment. Women eligible for this trial are those newly diagnosed with breast cancer (stages I,II, and III), who are about to undergo adjuvant AC chemotherapy. People who received neo-adjuvant treatment are not eligible, according to Cohen.

"As far as recruitment," he said, "we are still above the national average of three to four percent. Our problem has been that most women don't want to take the risk of being on the placebo. For many of them, it is hopefully the one and only time in their life that they will be undergoing chemotherapy. Why should they take the risk of not getting the herbs, after they have heard from so many people in support groups, friends, and family that herbs can help you go through the chemo? For many women in the Bay Area, it seems like common knowledge, and a placebo-controlled trial is useless for them individually."

While Cohen understands why women might not want to be randomized to placebo, he feels this is the only way to break down the barriers between different medical traditions. "Any claims made by myself or any other practitioner should be verified," he said. "The format of a clinical trial is not the greatest method of verification, but it is what we have now."

It would be ideal to be able to test the effectiveness of herbal therapy by letting all women receive the active herbal regimen, but that would not permit a true determination as to whether there is any benefit since there would not be any basis for comparison.

Benefits of Participation

This is the first and, so far, only place in the Western world where both traditional and alternative medicine practitioners are collaborating on patient care. The investigators will examine some specific immune properties that otherwise would not be examined.

"We all believe immune function has [something] to do with favorable outcome, but we know very little about it," Cohen said. "And we know even less about how to manipulate it without major side effects. So even if a woman is in the placebo group, we will know more about how the chemotherapy affected her immune system. If we see some difference between the groups, it will provide us with information that will aid the placebo group."

Cohen encourages women with breast cancer to be proactive. "Involving oneself in this trial is a bonus. AC chemo is very well studied. The control of most of the symptoms is done much better nowadays. We are not competing with chemotherapy; we are trying to enhance the effects. The herbal trial allows us to glance at functions other than cell killing.

"We are looking at the addition of a woman's well-being to the strategy of breast cancer treatment," he continued. "Well-being should not be approached hurriedly. The reason we have a placebo-controlled trial is to select and note differences in a small group of women."

Women interested in enrolling in this study should call Erika Lehmann at (415) 885-7328.

Tibetan Herbs and Breast Cancer

The second (and ongoing) trial involves the use of Tibetan herbs. Led by Yoshi Donda, a Tibetan monk who was the Dalai Lama's physician, the trial is examining the use of these herbs to treat metastatic breast cancer. Women with active, measurable metastatic breast cancer for whom chemotherapy has failed, those who are stable after chemotherapy, and those who. simply want to try the herbs can enroll for this trial by calling the Complementary and Alternative Medicine Program at the Breast Care Center, (415) 885-7328.

Metastatic Breast Cancer Trials

The third trial, which has not officially begun, will examine individualized Chinese herbal therapy for metastatic breast cancer, used alone or in conjunction with hormonal treatment. Women in the trial will receive herbal therapy as practiced in private clinics featuring traditional Chinese medicine.

"We are testing the use of Chinese medicine for metastatic disease, and we are testing a new method of obtaining clinical and psychosocial data," Cohen explained.

This trial is being conducted through an open registry that tracks information from the patient, her Western oncologist, and a Chinese medicine doctor. The aim, according to Cohen, is to provide a new concept for learning that includes more than just dry' objective data appropriate for chemotherapy drug trials.

"Chemotherapy is designed only to reduce tumor load by killing cells," he explained. "Counting on [that] as the only measure of success in cancer treatment is not wise."

Women interested in participating in this trial should call the Breast Care Center at (415) 885-7328.

Collaboration, Not Competition

Cohen and Tripathy stressed that these trials are not competing with chemotherapy. The trial for early stage breast cancer seeks to enhance chemotherapy results and ease the passage through adjuvant chemotherapy. The trials on metastatic breast cancer examine herbs as sole cancer therapy before or after chemotherapy.

"I think we need some new approaches to treatment soon," Cohen said. "The main difficulty, in my opinion, is not this or that trial. I think the main difficulty is that the approach is still very uncreative and does not include even a tiny portion of what we know about the biology of breast cancer. But we—providers and scientists—are all so busy making a living that we don't lift our heads to look at breast cancer from a new direction. It is very difficult to propose new hypotheses to funding agencies.

"Funding agencies have the responsibility to spend public money carefully," he continued, "and therefore are very cautious about granting money to new, unconventional ideas to study the treatment of breast cancer. I don't believe any of us has the solution to breast cancer, and there aren't any emerging winners or innovative new insights in the field yet."

Cohen believes that alternative healers and traditional physicians haven't yet started to truly collaborate. "We are just sniffing each other with suspicion and fear,". he said. "We need to struggle together to bring new and creative directions to the table that move us away from the pharmacological model and into an intelligent, information-driven, individualized care model."