Tibetan Medicine for Advanced Breast Cancer

Debasish Tripathy, M.D.
University of California, San Francisco

Standard treatment for metastatic breast cancer does not follow any rigid guidelines and is individualized depending on the patient’s tumor characteristics and clinical situation. Chemotherapy regimens and hormonal therapies can be effective for a variable period of time and in some cases the benefits of treatment in terms of improving symptoms and quality of life can outweigh the side effects. However, it has been difficult to show that standard or experimental treatments can prolong life significantly. Alternative and traditional approaches to medicine such as herbal and homeopathic medicine are widely used in the United States and throughout the world, although they have not been evaluated in formal clinical trials, especially in randomized trials. Therefore, it is difficult for patients and physicians to be able to logically choose what form of treatment might be most effective in controlling the cancer and maintaining an optimal quality of life.

We propose a method to start early testing of Tibetan Medicine as an example of a treatment that has been used for centuries, but has not been evaluated using clinical response criteria and quality of life analyses. The initial study will be an open study for all women with metastatic breast cancer that have no or minimal symptoms. Traditional diagnosis and herbal treatment by a world-recognized Tibetan physician will be conducted under the care of a California-licensed acupuncturist and herbalist. In parallel, patients will be seen and evaluated by a California-licensed and Board Certified medical oncologist experienced in clinical trials whose practice is devoted to breast cancer. A measurement of side effects, antitumor response or freedom from progression of tumor will be conducted. Quality of life and patient cost measures would be gathered and analyzed and a patient survey of standard and alternative medicine will also be conducted.

If this study demonstrates effectiveness in terms of tumor shrinkage or freedom of tumor growth that is nearly comparable to Western treatments such as chemotherapy or hormonal therapy, a randomized trial would then be designed as part of this project, though the actual study would be activated as a separate project. The direction set forth by this project would therefore be the development of a scientifically sound clinical trial method to properly evaluate alternative medical approaches for breast cancer.

Final Report (2001)

The purpose of the study was to determine the safety of diagnosis and treatment regimen by Tibetan medicine in patients with metastatic breast cancer without symptoms or with minimal symptoms due to cancer, and to determine the efficacy of Tibetan medicine as measured by time to disease progression, tumor response, and quality of life in this population of patients. Eleven patients agreed to participate in the study, and all met the inclusion criteria required for the study. Dr. Yeshi Dhonden prescribed an herbal regimen for each patient, and the examination was repeated every 3 to 4 months with changes in the formula as needed. Tumor measurements by physical examination and appropriate scans were performed at baseline and every 3 months along with monthly examinations and safety assessments. Of the 11 patients enrolled in the study, data for 9 patients were evaluated for response to therapy. One patient completed the study without disease progression, three patients were stable for 6-12 months, four patients were stable for less than 6 months, and one patient had a partial response to therapy using standard WHO response criteria. The patients participating in the trial did not experience any Grade III or IV toxicities attributable to the Tibetan herbal formula utilized. It can be noted, therefore, that the therapy used in this trial is both safe and feasible. Further studies of safety, feasibility and efficacy of Tibetan herbs are needed to evaluate a broader range of Tibetan herbal formulae.