Morrow, G. R., Hickok, J. T., Roscoe, J. A., Raubertas, R. F., Andrews, P. L., Flynn, P. J., . . . University of Rochester Cancer Center Community Clinical Oncology Program. (2003). Differential effects of paroxetine on fatigue and depression: a randomized, double-blind trial from the University of Rochester Cancer Center Community Clinical Oncology Program. Journal of Clinical Oncology, 21, 4635–4641

DOI Link

Intervention Characteristics/Basic Study Process

Patients were given oral paroxetine 20 mg orally daily or placebo for eight weeks.

Sample Characteristics

  • In total, 479 patients (paroxetine, n = 244; placebo, n = 235) were included.
  • Mean age was 56.5 years (standard deviation = 12.6 years) (range 27–87).
  • Most of the patients were female, 90% were Caucasian, 57% had breast cancer, and 14% had lung cancer.
  • All patients were receiving cyclic chemotherapy (but not concurrent with radiotherapy or interferon).

Setting

18 Community Clinical Oncology Program (CCOP) outpatient centers

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

The study was a randomized, double-blind, placebo-controlled trial.

Measurement Instruments/Methods

  • Fatigue Symptom Checklist (FSCL)
  • Multidimensional Assessment of Fatigue (MAF) (Question 1 only)
  • Monopolar Profile of Mood States (POMS) Short Form Fatigue/Inertia subscale

Results

The paroxetine group and the placebo control had comparable levels of fatigue and depression at study inception. Paroxetine had neither beneficial nor detrimental effects on fatigue. There was a significantly lower mean level of depression in the paroxetine group compared with the placebo group. Treatment with paroxetine also favorably affected patients’ general moods. There were no differences in the effect of paroxetine on fatigue by gender, age, indication for treatment (adjuvant treatment versus treatment for metastatic disease), or by whether patients were more or less fatigued at baseline.

Limitations

  • Whether the paroxetine group and the placebo control group had comparable hemoglobin levels at study inception is unknown.
  • Less than .01% (n = 2) of the patients in the paroxetine arm experienced adverse events (skin rash and pulmonary embolus) that were possibly related to the study medication.

Nursing Implications

No special training is required to deliver the intervention. There are costs related to drug acquisition.