Research and Clinical Trials -- Breast Cancer

Introduction | Protocol | Outcome

A Pilot Feasibility and Efficacy Study Assessing Tibetan Medicine for Metastatic Breast Cancer

Research Outcome

Primary Objectives

To determine the safety of diagnosis and treatment regimens by Tibetan medicine in patients with metastatic breast cancer without symptoms or with minimal symptoms due to cancer.

To determine the efficacy of Tibetan medicine as measured by tumor response, time to disease progression, and quality of life in this population of patients.

Secondary Objectives

These objectives are being collected to determine the feasibility of tracking this information. It is not expected that quantitative analyses can be performed on this information, but this will allow for the refinement of these tools to be used in subsequent studies.

To track cost and cost effectiveness of Tibetan medicine.

To obtain pilot information regarding the attitudes and expectations of alternative and conventional medicine for breast cancer among patients that enroll on this trial.

Long Range Objectives

Long range objectives (beyond this trial) are to develop a methodology to test other alternative forms of medicine using standard clinical trial methodology that can ultimately compare benefits to standard therapies.

In the case of Tibetan medicine, this trial would be followed by a randomized trial comparing Tibetan medicine to observation for asymptomatic patients or to a predetermined standard hormonal or chemotherapeutic regimen for symptomatic patients (or patients felt to require treatment of known efficacy due to expected complications of disease progression). The safety of Tibetan medicine as well as expected benefits used to calculate sample sizes would be based, in part, on the results from this Phase I/II study.

Eligibility Inclusion

Criteria Patients with a histologically confirmed diagnosis of breast cancer and clinical evidence of metastatic involvement who are asymptomatic or minimally symptomatic and felt not to be at immediate risk of organ or tissue damage as a result of short term tumor progression are eligible for this study.

All patients will be receiving no anti-tumor therapy (hormonal therapy or chemotherapy), and no investigational agents or herbal/alternative medications other than those that are part of the study. Patients may have received any of these treatments in the past and must have discontinued them 3 weeks prior to enrollment.

Specifically, therapy with hormonal or chemotherapeutic agents must be declined at the current time (this is even in cases where such treatment might not be standardly recommended at the given time in the patient's course). Intercurrent use of radiation therapy is permitted as medically indicated as is any other medical treatment that is not directed against tumor.

All patients need to have been fully informed of other treatment options including chemotherapy, hormonal therapy, and other available clinical trials and have chosen Tibetan Medicine alone. Alternative modalities other than herbal therapies are allowed.

Exclusion Criteria

• Extensive liver involvement (greater than 50 of liver parenchyma).
• Lymphangitic pulmonary involvement.
• Central nervous system involvement or spinal cord compression. Symptoms including but not limited to shortness of breath due to lung involvement and moderate to severe bone pain related to tumor.
• Inability to provide informed consent.
• History of multiple or severe food or medicine allergies.
• Organ or marrow dysfunction as defined by:
  • Creatinine greater than 2.0 mg/dl.
  • Total bilirubin greater than 1.7 mg/dl.
  • White blood cell count less than 2.5.
  • platelet count less than 75,000.
  • ECOG performance status score of 2 or higher.

Excerpts from "Healing from the Source"
Excerpts from "Health Through Balance"
Dr. Dhonden's Books
Tibetan Medicine: Books and Resources
Dr. Yehsi Dhonden