Boekhout, A. H., Vincent, A. D., Dalesio, O. B., van den Bosch, J., Foekema-Tons, J. H., Adriaansz, S., . . . Schellens, J. H. (2011). Management of hot flashes in patients who have breast cancer with venlafaxine and clonidine: a randomized, double-blind, placebo-controlled trial. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 29(29), 3862-3868.doi:10.1200/JCO.2010.33.1298
Evaluate the efficacy of venlaxafine and clonidine for hot flashes in patients with breast cancer
Patients were randomly assigned to receive 75 mg venlafaxine, 0.1 mg clonidine, or placebo daily. Subjects were stratified by age, duration of hot flashes, concurrent endocrine therapy, and previous chemotherapy. Patients were treated for 12 weeks. Hot flash scores at week 12 were compared among the three groups.
N 80 AGE Median = 49, range 28-71
MALES (%) FEMALES (%)100%
KEY DISEASE CHARACTERISTICS 31% had age related symptoms, and 99% were post menopausal after breast cancer treatment. 52% received endocrine treatment
SITE Multi-site SETTING TYPE Outpatient LOCATION Netherlands
PHASE OF CARE Late effects and survivorship
Double blind placebo controlled RCT
Hot flash scores were lower in the clonidine group than the placebo group at week 12 ( p = .03), and lower in the venlaxafine group than placebo, though not statistically significant ( p = .07). Over the 12-week period, reduction in the venlaxafine group was 41% ( P<.001), 26% in the clonidine group ( p=.045), and 29% in the placebo group (p<.001). Those on venlaxafine tended to have some loss of appetite ( p = .003) as well as symptoms of nausea. Sleep and sexual function were not different between the two treatment groups. At week 12, anxiety and depression scores were higher in the venlafaxine than the clonidine group. (p = .03). Significantly lower hot flash scores began in the venlafaxine group compared to placebo in weeks 1-4 (p =.01), and in the clonidine group, lower scores began compared to placebo in weeks 5-8 ( p = .04)
Both venlafaxine and clonidine were slightly more effective than placebo in reducing hot flash symptoms in this group of patients. However, over the 12 weeks, all study groups showed significant reduction in symptoms.
Findings suggest that venlafaxine and clonidine may be of benefit in reducing hot flash symptoms in women with breast cancer. However, further research is needed for support, because placebo group also showed reduction in hot flashes. Some patients did have side effects from these medications; patients should be monitored for nausea, changes in appetite, anxiety, and depression if these medications are used.