Palesh, O. G., Mustian, K. M., Peppone, L. J., Janelsins, M., Sprod, L. K., Kesler, S., . . . Morrow, G. R. (2012). Impact of paroxetine on sleep problems in 426 cancer patients receiving chemotherapy: a trial from the University of Rochester Cancer Center Community Clinical Oncology Program. Sleep Medicine, 13, 1184–1190.doi: 10.1016/j.sleep.2012.06.001
To compare the effects of paroxetine to placebo on sleep problems in patients with cancer.
This study was a post hoc analysis of data from a randomized, controlled trial (RCT) previously implemented to examine the effects of paroxetine on fatigue. Patients seen between 1997 and 1999 with any type of cancer receiving chemotherapy were recruited and randomized to either 20 mg of paroxetine daily or placebo. Data were collected seven days after each chemotherapy cycle. Patients received follow-up and reminder telephone calls from the study nurse. For analysis purposes, patients were classified as those with sleep problems or good sleepers based on depression inventory scores. Those who reported sleep difficulties of any type at least one to two nights a week were classified as having sleep problems. Responses to single items regarding sleep on rating scales used in the study were used as primary outcome measures.
Patients were undergoing the active antitumor treatment phase of care.
The study was a secondary analysis of a double-blind, placebo-controlled RCT.
At the end of cycle 4 of chemotherapy, there was a significant difference in the prevalence of patients with sleep problems between those on paroxetine (79.3%) versus placebo (88%) (p = 0.01; d = 0.23). Rates of severity of sleep problems were not significantly different between the groups.
The findings provide relatively weak evidence that paroxetine may help patients with cancer undergoing treatment to reduce the prevalence of mild sleep problems. Validated sleep quality measures were not used.
Further research on the effects of selective serotonin reuptake inhibitors (SSRIs) to improve sleep in patients with cancer who have sleep problems is needed. The positive findings are limited by the measurement of sleep problems and the fact that this analysis was performed from a study that was not designed to measure the outcome of sleep.