Cancer survivors tend to struggle with insomnia. Unfortunately, the treatment for insomnia in these individuals is more complicated than in the general population.
The standard treatment of cognitive behavioral therapy for insomnia (CBT-1) can result in transient but substantial increases in daytime sleepiness and impaired function due to the daytime sleepiness restriction that is required with CBT-1
CBT-1 is a multicomponent intervention that looks to identifying and correcting sleep interfering activities, regularizing the sleep-wake cycle and diminishing or modifying stressful thoughts that interfere with sleep.
To counteract this, researchers are investigating if the use of a wakefulness-promoting drug would benefit this patient population.
This study was published online in the journal of Clinical Oncology
The team concluded that the pharmacologic agent armodafinil did not improve on the efficacy seen with CBT-1 when was given alone or in combination with CBT-1 in cancer survivors.
Researchers assert that the failure of armodafinil to produce benefits to those of CBT-1 for the treatment of insomnia should discourage the use of this drug in oncologic practice.
The study was randomized, double-blind, placebo-controlled study undertaken in 96 cancer survivors from two Northeastern cities. The target accrual of 226 participants with an assumed attrition of 20% was not met. Of 138 patients who consented to an initial screening, 114 patients were eligible for the study and 96 were randomized to four groups.
Patients received one of four treatments: CBT-1 and a placebo, CBT-1 and armodafinil 50 mg twice daily; armodafinil 50 mg twice daily; placebo. The treatments were given for 40 days. CBT-1 was given over the course of seven weeks, once weekly and conducted over the phone.
The average compliance rate across all the four arms of the study was greater than 90%.
The study also showed that CBT-1 produced strong and consistent reductions in ISI with or without armodafinil, showed rapid improvement as early as week 2, and effects were sustained through the remainder of the study and remained stable three months after its conclusion.