Susan G Komen  
I've Been Diagnosed With Breast Cancer Someone I Know Was Diagnosed Share Your Story Join Us And Stay Informed Donate To End Breast Cancer
    Home > Research & Grants > Grants Program > Research Grants > Research Grants Awarded > Abstract
    Awarded Grants
    Treatment of Hot Flashes in Breast Cancer Survivors: A Pilot Study

    Scientific Abstract:
    Breast cancer is the most common type of cancer among women. Many breast cancer survivors are treated with selective estrogen-receptor modulators (SERMs) and/or aromatase inhibitors (AIs). Unfortunately, use of these treatments is associated with several side effects, in particular hot flashes. In fact, breast cancer patients have a three-fold increased risk of developing hot flashes. Use of hormone replacement therapy to treat hot flashes is contraindicated in women with breast cancer and is associated with increased risk for serious health consequences. Therefore, the hot flashes associated with these drugs often go untreated or are managed with selective serotonin reuptake inhibitors (SSRI). Hot flashes are believed to be the result of waning estrogen levels that result, in part, in a decrease in serotonin levels. Treatments that increase synaptic serotonin levels have demonstrated efficacy in the reduction of vasomotor symptoms. Given the relationships between serotonin and hot flashes; and the neuropharmacologic effects of nicotine, specifically on serotonin, it is reasonable to hypothesize that nicotine would be efficacious in reducing hot flashes. Further, nicotine therapy has a low abuse profile, is associated with few side effects and is a readily available over-the-counter medication. To date, there have been no clinical trials comparing the nicotine patch with a placebo as a therapy for the vasomotor symptoms associated with SERM or AI use. Given that nicotine increases synaptic serotonin levels, as do SSRI’s, it is reasonable to expect that this treatment will be efficacious and warrants investigation. Therefore, we propose to evaluate the efficacy of the nicotine patch as a treatment for the hot flashes associated with SERM and AI treatment in a double-blind, placebo-controlled, cross-over pilot study by randomizing nonsmoking women who are treated with these drugs and with moderate to severe hot flashes, to one of four groups: Group 1) 7mg Nicotine Patch followed by Placebo 7mg Patch; 2) Placebo 7mg Patch followed by 7mg Nicotine Patch; 3) 14mg Nicotine Patch followed by Placebo 14mg Patch; or 4) Placebo 14mg Patch followed by 14mg Nicotine Patch. There will be a two-week wash out period between patch conditions. The primary outcome measure will be the change in the mean number of hot flashes/night sweats per week over a 10-week period. The impact on quality of life, sleep, and depression will also be evaluated.

    Lay Abstract:
    Breast cancer is the most common type of cancer among women. Many breast cancer survivors are treated with two different types of medication: selective estrogen-receptor modulators (SERMs) and/or aromatase inhibitors (AIs). Unfortunately, use of these drugs is associated with several side effects, hot flashes in particular. In fact, breast cancer patients have an increased risk of developing hot flashes. Hot flashes impact the quality of everyday life and are generally treated with hormone replacement therapy. This treatment, however, is not appropriate for breast cancer survivors and is associated with increased risk for serious health consequences. Therefore, the hot flashes associated with these drugs often go untreated or are managed with a particular class of prescription drugs, known as selective serotonin reuptake inhibitors (SSRIs). Hot flashes are believed to be the result of waning hormone levels that result, in part, in lower levels of serotonin (a chemical in the body). Drugs that increase serotonin have been shown to reduce hot flashes. Another medication that increases serotonin is the nicotine patch. Nicotine therapy relative to prescription drugs has few side effects and is available over-the-counter. There have been no studies comparing the nicotine patch with a placebo patch (a patch with no drug) as a therapy for the hot flashes associated with the drugs used to treat breast cancer survivors. Because nicotine increases serotonin levels, as do SSRIs, it is reasonable to expect that this treatment may be effective and warrants investigation. Therefore, this study will evaluate the effectiveness of the nicotine patch as a treatment for the hot flashes associated with SERM and AI treatment by assigning by chance nonsmoking women, with moderate to severe hot flashes, who are treated with these drugs, to one of four groups: Group 1) 7 mg nicotine patch followed by placebo 7 mg patch; 2) placebo 7 mg patch followed by 7 mg nicotine patch; 3) 14 mg nicotine patch followed by placebo 14 mg patch; or 4) placebo 14 mg patch followed by 14 mg nicotine patch. The women will not know which patch they are on at any time during the study. We will measure the change in the number of hot flashes experienced by each group over a 10-week period. Women in the study will also be asked to answer questions about the quality of daily living, sleep, and depression.