Effectiveness Not Established

Thyrotropin Releasing Hormone (TRH)

for Fatigue

TRH is a hormone that stimulates release of thyroid-stimulating hormone from the pituitary gland. TRH has been studied in patients with cancer for its effect on fatigue.

Research Evidence Summaries

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.

Study Purpose

To evaluate the efficacy and safety of thyrotropin-releasing hormone (TRH) compared with placebo to treat idiopathic cancer-related fatigue (CRF).

Intervention Characteristics/Basic Study Process

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.

Sample Characteristics

  • The sample was comprised of eight patients (one man, seven women). 
  • Mean age was 58 years (SD = 9.4 years).
  • Patients scored less than 34 on the Functional Assessment of Cancer Therapy–Fatigue (FACT-F) subscale and met the International Classification of Diseases, Tenth Revision (ICD-10) criteria.
  • All patients were at least 18 years of age and at least one month postchemotherapy.

Setting

  • Single site
  • Outpatient
  • University of Connecticut Health Center

Phase of Care and Clinical Applications

Patients were undergoing the transition phase after active treatment.

Study Design

The study used a pilot, phase II trial, double-blind, placebo-controlled, crossover design with two randomizations.

Measurement Instruments/Methods

  • Visual analog scale for energy level (VAS-E)
  • Profile of Mood States (POMS) scale 
  • Hospital Anxiety and Depression Scale (HADS)
  • 6-minute walk test (6MWT)
  • Leeds Sleep Evaluation Questionnaire (LSEQ)
  • Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F)

Results

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.

Conclusions

TRH was safe and well tolerated by the patients. The results suggested significant beneficial effects of intravenous TRH in the treatment of CRF.

Limitations

  • The study had a small sample size, with less than 30 patients.
  • The study had a risk of bias due to the sample characteristics.
  • Key sample group differences could have influenced the results.
  • The findings were not generalizable.
  • Patient withdrawals were 10% or greater. 

Nursing Implications

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.

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