Goldberg, R.M., Loprinzi, C.L., O’Fallon, J.R., Veeder, M.H., Miser, A.W., Mailliard, J.A., … Burnham, N.L. (1994). Transdermal clonidine for ameliorating tamoxifen-induced hot flashes. Journal of Clinical Oncology, 12, 155–158.

The study evaluated transdermal clonidine for alleviating tamoxifen-induced hot flashes in women with a history of breast cancer.

Four weeks of transdermal clonidine (equivalent to a daily oral dose of 0.1mg) was followed by four weeks of placebo patches or vice versa. Patches were changed weekly.

The study enrolled 116 women with a mean age of 54 years who were receiving tamoxifen for breast cancer experiencing hot flashes and requesting intervention; experiencing hot flashes for longer than one month and at least seven per week. One hundred ten (110) of the 116 completed the study. Participants were stratified by age, duration of hot flash symptoms, and the average frequency and severity of hot flashes.

This was a randomized, double-blind, crossover prospective study.

The study employed the following measures:

• Daily self-administered patient questionnaires
• Weekly questionnaires
• Nurse assessment every two to three weeks for compliance, toxicity profile, and standard questions
• Hot flash severity and frequency measures and combined hot flash score

The study showed a statistically significant decrease in hot flashes (frequency and severity) (p < .0001), and clinically moderate decreases in frequency (20%) and severity (10%). Toxicities included dry mouth (p < .001) and constipation (p < .02).

Small study size limited the value of the outcomes.