Dang-Gui-Liu-Huang-Tang, a Chinese herbal medicine formula, may relieve breast cancer patients’ side effects under adjuvant chemotherapy: a randomized placebo-controlled trial.

INTERVENTION: Dang‐Gui‐Liu‐Huang‐Tang is a classic Traditional Chinese Medicine (TCM) formula commonly made for menopausal syndrome by modulating patients' immunity and endocrine imbalance. Since severe menopausal syndrome and discomforts following treatment for breast cancer could be seen among breast cancer patients, Dang‐Gui‐Liu‐Huang‐Tang is therefore used for breast cancer patients in clinical practice for symptom relief. For this reason, this study is being conducted to examine the effect of Dang‐Gui‐Liu‐Huang‐Tang as an additional therapy for breast cancer. Dang‐Gui‐Liu‐Huang‐Tang is given three times a day, 4 grams each time, along with chemotherapy for breast cancer. For example, cyclophosphamide‐fluorouracil‐methotrexate (CMF) chemotherapy will be given every three weeks, for a total of 9 rounds of CMF treatment; while cyclophosphamide, epirubicin, fluorouracil (CEF) will be given every three weeks, for a total of 6 rounds of CEF treatment. On the other hand, placebo medicine with similar color and smell is given at the same frequency and quantity. All enrolled patients are assigned to treatment using a number generated by a random sequence and equally distributed to two groups in 1:1 ratio. Principal investigator (PI) and co‐PIs are responsible for patient evaluation; research assistants have expertise in collecting patients' information and lab data. Additionally, TCM pharmacists are responsible for delivering trial medicine to enrolled subjects. All medicines are delivered face‐to‐face by TCM pharmacists after recognizing the assigned number of each subject. The entire trial will be conducted in the Chang‐Gung Memorial Hospital, Linkou branch, Taoyuan, Taiwan. CONDITION: Relief of side effects of chemotherapy among breast cancer patients ; Cancer PRIMARY OUTCOME: Side effects measured using the MD Anderson Symptom Inventory (MDASI), the Functional Assessment of Cancer Therapy ‐ Breast (FACT‐B) questionnaire and CTCAE 4.0 grading from day 0 and every three weeks SECONDARY OUTCOME: Neutrophil function measured using a neutrophil phagocytosis assay at day 0 and every 3 weeks INCLUSION CRITERIA: 1. Breast cancer patient receives adjuvant chemotherapy 2. Age ranges from 18 to 65 years 3. Not receiving Chinese herbal medicine within one month before enrollment 4. Adequate bone marrow reserve: platelets?100*10^9/L, absolute neutrophil count (ANC) ?1.5*10^9/L, hemoglobin?9.0g/d, adequate liver function tests: serum bilirubin <1.5mg/dL, ALT and AST <2.5*ULN, adequate renal function: creatinine ?2 mg/dL or estimated creatinine clearance >40mL/min, calcium?1.2*ULN 5. Diagnosed as the Traditional Chinese medicine (TCM) pattern "Qi and blood deficiency" by a TCM doctor 6. Willing to sign the informed consent