Efficacy and Safety of Jollab (a Saffron-Based Beverage) on Cancer-Related Fatigue in Breast Cancer Patients: A Double-Blind Randomized Clinical Trial.

INTRODUCTION: Fatigue is a common complaint in cancer patients and profoundly affects the quality of life of the patients. Therefore, we designed a clinical trial to evaluate the safety and efficacy of Jollab (containing saffron, honey, and rose water) as a tonic beverage in the management of cancer-related fatigue in breast cancer patients. METHODS: Seventy-five patients were randomly assigned into two groups, patients received either 4 weeks Jollab or the placebo (20 mL three times daily). Fatigue was assessed with scores of Visual Analogue Fatigue Scale (VAFS), Fatigue Severity Scale (FSS), and Cancer Fatigue Scale (CFS) at weeks 0 and 4 (before and after the intervention). RESULTS: In the Jollab group, VAFS showed a significant decrease (p = 0.000), but in the placebo group, there was no significant difference (p = 0.258). In the Jollab group, FSS decreased significantly (p = 0.000), while in the placebo group, it slightly decreased (p = 0.096). CFS physical and cognitive subscales also showed improvement of fatigue in the Jollab group compared to the placebo group (p < 0.05), but affective subscale score did not show a significant change after the intervention in both groups (p > 0.05). CONCLUSIONS: Jollab beverage has significant positive effects on reducing fatigue in women with breast cancer. However, larger-scale trials with further sample size and longer period of the intervention are needed to confirm and develop our preliminary findings.