Nunez, G.R., Pinczowski, H., Zanellato, R., Tateyama, L., Schindler, F., Fonseca, F., & Del Giglio, A. (2013). Bupropion for control of hot flashes in breast cancer survivors: A prospective, double-blind, randomized, crossover, pilot phase II trial. Journal of Pain and Symptom Management, 45, 969–979.

DOI Link

Study Purpose

To evaluate the efficacy of a smoking cessation medication in controlling symptoms of hot flashes in patients with breast cancer receiving hormonotherapy

Intervention Characteristics/Basic Study Process

In the first phase of this crossover clinical trial, the intervention group received bupropion 150 mg for three days and 300 mg during the rest of the four-week period. The control group received placebo in the same four weeks. After one week of washout time, the groups were combined and crossed over to receive the same dose as the intervention or placebo at the beginning for four more weeks. The study was 10 weeks in length for both groups.

Sample Characteristics

  • N = 55  
  • MEAN AGE: 49 years (33–71 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Women with breast cancer undergoing hormonal therapy, with seven or more hot flashes per week
  • OTHER KEY SAMPLE CHARACTERISTICS: Not tumor disease, already completed active treatment at least three months prior

Setting

  • SITE: Single site  
  • SETTING TYPE: Not specified   
  • LOCATION: Foundation School of Medicine, Sao Paulo, Brazil

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late effects and survivorship
  • APPLICATIONS: Elder care, palliative care

Study Design

  • Double-blinded clinical trial
    • Randomized, placebo-controlled, crossover, pilot

Measurement Instruments/Methods

  • A daily diary on the number and severity of hot flashes
  • ASEX scale to assess sexual function
  • Beck Depression Inventory (BDI)
  • Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
  • Blood pressure and heart rate to evaluate physical signs

Results

The reduction in hot flashes for the intervention group was 1.26 per day, without any difference in sexual function occurring nor statistical significance of side effects experienced between groups.

Conclusions

There was no activity shown for bupropion over placebo for control of hot flashes.

Limitations

  • Small sample (< 100)

 

Nursing Implications

Bupropion is not recommended in practice for women with breast cancer. It was not statistically significant in controlling the symptoms of hot flashes in comparison with the placebo group.