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.

Dang-Gui-Liu-Huang-Tang for breast cancer patients’ side effects

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN36204437

Enrollment

118

Registered

2023-10-24

Start date

2008-11-01

Completion date

Unknown

Last updated

2023-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relief of side effects of chemotherapy among breast cancer patients Cancer

Interventions

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

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 gi

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

Eligibility

Sex/Gender

Female

Inclusion criteria

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 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

Exclusion criteria

Exclusion criteria: 1. Patients receive concurrent therapies other than chemotherapy, such as radiotherapy or hormone therapy, or are unsuitable for chemotherapy 2. With severe underlying diseases, mental illness, and infectious diseases 3. Women with breastfeeding or pregnancy 4. Subjects with cardiovascular diseases but without adequate treatments or with a history of myocardial infarction within recent six months 5. Not diagnosed as Traditional Chinese medicine (TCM) pattern "Qi and blood deficiency" 6. Chemotherapy is stopped and will not be continued within one month 7. Any intolerant adverse events during the study period 8. Subjects with liver or renal function deteriorating, and the discontinuation of the clinical trial is requested by investigators

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Neutrophil function measured using a neutrophil phagocytosis assay at day 0 and every 3 weeks	—

Countries

Taiwan

Contacts

Public ContactHsing-Yu Cheng

b8705016@gmail.com+886975366119

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026