title: Effect of Withania somnifera (Ashwagandha) on the development of chemotherapy-induced fatigue and quality of life in breast cancer patients.
abstract: Hypothesis. Withania somnifera is an herb with antioxidant, anti-inflammatory, anticancer, antistress, and adaptogenic properties. Previous studies have shown its antistress effects in animals. Traditional Indian medicine has used it for centuries to alleviate fatigue and improve general well-being.
  
  
  METHODS
  This is an open-label prospective nonrandomized comparative trial on 100 patients with breast cancer in all stages undergoing either a combination of chemotherapy with oral Withania somnifera or chemotherapy alone. The chemotherapy regimens were either taxotere, adriamycin, and cyclophosphamide or 5-fluorouracil, epirubicin, and cyclophosphamide. Withania somnifera root extract was administered to patients in the study group at a dose of 2 g every 8 hours, throughout the course of chemotherapy. The quality-of-life and fatigue scores were evaluated before, during, and on the last cycles of chemotherapy using the EORTC QLQ-C30 (Version 3), Piper Fatigue Scale (PFS), and Schwartz Cancer Fatigue Scale (SCFS-6).
  
  
  RESULTS
  The median age distributions in the study and control arm were 51 years (range = 36-70) and 50.5 years (range = 32-71), respectively. The majority (77%) of patients had stage II and III disease. Patients in the control arm experienced statistically significant higher estimated marginal means of fatigue score compared with the study group (P < .001 PFS, P < .003 SCFS-6). Furthermore, various symptom scales of the EORTC QLQ-C30 were statistically significant in 7 out of 18 symptoms in the intervention group compared with the control group (P < .001). The 24-month overall survival for all stages in study and control group patients were 72% versus 56%, respectively; however, the result was not significant (P = .176), at a median follow-up duration of 26 months.
  
  
  CONCLUSIONS
  Withania somnifera has potential against cancer-related fatigue, in addition to improving the quality of life. However, further study with a larger sample size in a randomized trial is warranted to validate our findings.
authors.affiliation: Department of Nuclear Medicine, Radiotherapy & Oncology, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia. biswa@kb.usm.my
authors.forename: Biswa Mohan
authors.initials: BM
authors.lastname: Biswal
authors.forename: Siti Amrah
authors.initials: SA
authors.lastname: Sulaiman
authors.forename: Hasanah Che
authors.initials: HC
authors.lastname: Ismail
authors.forename: Hasmat
authors.initials: H
authors.lastname: Zakaria
authors.forename: Kamarul Imran
authors.initials: KI
authors.lastname: Musa
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy*; D005221:Fatigue / Q000139:chemically induced* / Q000188:drug therapy*; D005260:Female; D006801:Humans; D055118:Medication Adherence; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use*; D011788:Quality of Life; D016896:Treatment Outcome; D032341:Withania
chemical_list: D010936:Plant Extracts
keywords: Withania somnifera; breast cancer; chemotherapy; fatigue; quality of life