Roscoe, J. A., Morrow, G. R., Hickok, J. T., Mustian, K. M., Griggs, J. J., Matteson, S. E., . . . Smith, B. (2005). Effect of paroxetine hydrochloride (Paxil) on fatigue and depression in breast cancer patients receiving chemotherapy. Breast Cancer Research and Treatment, 89, 243–249.

Patients were given oral paroxetine 20 mg daily beginning seven days after the initiation of the first cycle of chemotherapy for newly diagnosed breast cancer and continued until seven days following their fourth cycle of chemotherapy or placebo. Randomization was stratified by type of chemotherapy regimen to achieve a balanced design.

• The sample was comprised of 94 women with breast cancer initiating at least four cycles of chemotherapy for breast cancer.
• Mean age was 51.2 years (range 31–79). 
• Of the patients, 89% were Caucasian, 28% were significantly depressed at baseline, and 5% had a hemoglobin less than 11 g/dL.
• There were no significant differences between the intervention and placebo control groups in age, mean baseline measures of fatigue, depression, or general health status.
• The difference in baseline hemoglobin between the intervention group (12.3 g/dL) and the placebo control group (12.9 g/dL) was statistically significant (p < 0.05).

Patients were recruited from a university medical center and two of its affiliated hospitals.

Patients were undergoing the active treatment phase of care.

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

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

Controlling for baseline fatigue scores, there were no statistically significant differences in fatigue or fatigue interference between the treatment and control groups. There was no relationship between anemia and fatigue at baseline, although changes in anemia over the course of the study were modestly but significantly correlated with one measure of fatigue.

• No power analysis was provided; it was unclear if the study was appropriately powered to detect a difference in fatigue.
• Anemia was not included as a covariate in the analyses.
• Six patients withdrew due to side effects, such as nausea and headache.

There were costs related to drug acquisition.