Dexamethasone for 12 weeks for reducing fatigue in patients receiving palliative chemotherapy: A Phase 3, Placebo-Controlled, Randomized Controlled Trial.

PURPOSE: Cancer-associated fatigue is a prevalent and distressing symptom in patients receiving palliative chemotherapy. While short-term steroid use has been employed to alleviate fatigue, its long-term efficacy and safety remain unclear.

METHODS

This phase III open-label, placebo-controlled randomized trial evaluated the efficacy and safety of dexamethasone (4 mg once daily for 12 weeks) versus placebo (once daily for 12 weeks) in patients with solid malignancies undergoing palliative chemotherapy. Fatigue was assessed using the Symbolic Assessment of Fatigue Extent (SAFE) and EORTC FA-12 scales, and quality of life (QOL) was measured using the EORTC QLQ-C30 at baseline, 6 weeks, and 12 weeks.

RESULTS

From October 2018 to September 2022, 126 patients were randomized; 101 were evaluable (dexamethasone: 49, placebo: 52). The median age was 46.5 years, and 67% were female. Metastatic breast cancer (28%) and lung cancer (16%) were the most common diagnoses. There were no significant differences between the arms in mean SAFE scores at 6 or 12 weeks. At 12 weeks, patients in the placebo arm reported better role functioning on the FA-12 (P = 0.02). In the EORTC QLQ-C30, the dexamethasone arm had more constipation at 6 weeks (P = 0.03) and 12 weeks (P = 0.01), and greater social sequelae at 12 weeks (P = 0.048). No significant differences in adverse events were observed between the arms.

CONCLUSION

Dexamethasone did not significantly reduce cancer-associated fatigue or improve QOL in patients receiving palliative chemotherapy. The findings highlight the need to explore alternative, more effective interventions for managing fatigue in this population.

TRIAL REGISTRATION: CTRI/2018/08/015222, date: 07/08/2018.