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.

Phase 2

Completed

• Conditions: Relief of side effects of chemotherapy among breast cancer patients; Cancer

• Registration Number: ISRCTN36204437
• Lead Sponsor: Chang Gung Medical Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2011-11-30
• Study Start: 2023-10-24
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 112

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
eutrophil function measured using a neutrophil phagocytosis assay at day 0 and every 3 weeks