AOS14 Phase II clinical study of combination chemotherapy with herb Withania somnifera (ashwagandha) in breast cancer

Background Herbal drugs are generally avoided during systemic chemotherapy because of herb–drug interaction and exaggeration of chemotherapy-related toxicity. We used a common medicinal herb Withania somnifera (ashwagandha) in addition to systemic chemotherapy in patients with breast cancer. This herb is haemoprotective, enhances cytotoxicity of chemotherapy, has radiosensitive properties, and improves the general wellbeing of patients. Methods This was a prospective non-randomised clinical trial comparing the outcomes of W. somnifera plus chemotherapy with chemotherapy alone (control) in women with breast cancer. Fifty patients with all stages of breast cancer that required systemic chemotherapy were alternatively assigned to study drug or no further treatment using defined selection criteria. W. somnifera root extract in vegetarian capsule form was given at an oral dose of 2 g tds during six courses of chemotherapy to the patients in the combination group. Piper’s fatigue score (PFS), Schwartz’s cancer fatigue score (SCFS), European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C-30 (version 3) at the beginning (1st cycle), during, and after chemotherapy (6th cycle), clinical parameters, and response to therapy in both groups were monitored. The haematological parameters were monitored during the six cycles of chemotherapy. Correlation of the quality of life (QoL) and fatigue over time as numerical covariates was evaluated using the repeated-measure analysis of covariance (ANCOVA) method, and survival analysis was done with Kaplan–Meier non-parametric estimation using SPSS (version 18, IBM) software. Findings Fifty patients were recruited to each group, with a median age of 51 years (range 36–70 years) in the W. somnifera plus chemotherapy group and 50.5 years (range 30–82 years) in the control group. Eight patients had stage I, 33 stage II, 44 stage III, and 15 stage IV breast cancer. Fifteen patients were offered palliative chemotherapy and 85 were offered adjuvant chemotherapy. Patients in the group treated with W. somnifera root extract and chemotherapy had less fatigue than did those in the control group (PFS p p p  = 0.0001) than in the control group. There was no difference in the haematological parameters or 24-month overall survival for all stages [study 74% versus control 56% ( p  = 0.174)]; however, there was a trend for longer survival in the patients treated with W. somnifera root extract plus chemotherapy. Interpretation Addition of W. somnifera to chemotherapy could have a positive effect on fatigue and improve QoL in patients with breast cancer. The effectiveness and toxicity of chemotherapy were not altered. Thus further study with a large sample size, uniform tumour criteria, and risk stratified patients with breast cancer could help to validate our preliminary outcome. Funding RU grant of University Sains Malaysia (2009-02011). The authors declared no conflicts of interest.