Kamath, J., Feinn, R., & Winokur, A. (2012). Thyrotropin-releasing hormone as a treatment for cancer-related fatigue: a randomized controlled study. Supportive Care in Cancer, 20, 1745–1753.
To evaluate the efficacy and safety of thyrotropin-releasing hormone (TRH) compared with placebo to treat idiopathic cancer-related fatigue (CRF).
Patients received four study medication bolus infusions, once a week, over a four-week period. The infusions were separated by one week (plus/minus one day). Two of the infusions were TRH at doses of 0.5 and 1.5 mg (lower dose given first), and the other two infusions were placebo. Fatigue assessments were obtained at baseline.
Patients were undergoing the transition phase after active treatment.
The study used a pilot, phase II trial, double-blind, placebo-controlled, crossover design with two randomizations.
Improvements in energy level (p = 0.004 for 0.5 mg TRH and p = 0.002 for 1.5 mg TRH), vigor and fatigue, and sleep disturbance were markedly higher for both TRH doses compared with placebo (saline infusion) throughout the interval from baseline through 72 hours postinfusion. No significant difference existed in energy level between the two doses. The walking test scores and the anxiety and depression symptoms showed no statistically significant difference between TRH and placebo. Side effects included modest increases in blood pressure, heart rate, nausea, flushing, and bladder sensation or urge to urinate.
TRH was safe and well tolerated by the patients. The results suggested significant beneficial effects of intravenous TRH in the treatment of CRF.
More data are needed to confirm these findings with a larger population. Nurses can encourage patients with prominent fatigue symptoms to enter a clinical trial testing the efficacy of TRH.