Formulation of Viola odorata L. Tablet and Evaluation of The Product Effect on Breast Cancer-Related Fatigue: A Randomized, Controlled Pilot Trial

This study was designed to formulate a Viola odorata L. tablet (VOT) and evaluate its efficacy in managing cancer-related fatigue (CRF) in breast cancer patients undergoing radiotherapy. The tablet was formulated and subjected to quality control tests. The pilot study was conducted as a randomized, double-blind trial. A total of 18 breast cancer patients were enrolled and randomly assigned to two groups. The intervention and control groups received VOT/bis in die (Bid) and placebo, respectively, for 4 weeks. All the patients completed the visual analog fatigue scale (VAFS), fatigue severity scale (FSS), and cancer fatigue scale (CFS) questionnaires before and after the intervention. The best tablet formulation contained V. odorata extract 486 mg, PVPK30 50 mg, lactose 450 mg, Avicel PH102 100 mg, SiO2 14 mg, and magnesium stearate 20 mg. Dimensions, disintegration time, hardness, friability, weight, and total phenolics as pyrogallol were 7.1×9.9×30.3 mm, 28 min, 9.5 kp, 0.37%, 1120mg, 22.8 mg/tab, respectively. More than 80% of the phenolics in the tablets were dissolved during the dissolution test in 30 min. In the pilot study, only VOT treatment significantly decreased the VAFS (p = 0.02), FSS (p = 0.08), and CFS (p=0.03) scores. The results indicated desirable VOT physicochemical characteristics and suggested it as an herbal product for managing CRF in breast cancer patients.