PURPOSE:Hot flashes represent a substantial clinical problem for some breast cancer survivors. Although estrogen or progesterone preparations can alleviate these symptoms in many patients, concern remains regarding the use of hormonal preparations in such women. Thus, there is a perceived need for nonhormonal treatments for hot flashes for breast cancer survivors. Based on anecdotal evidence that vitamin E was helpful, we designed a trial to investigate this matter. METHODS: We developed and conducted a placebo-controlled, randomized, crossover trial where, after a 1 week baseline period, patients received 4 weeks of vitamin E 800 IU daily, then 4 weeks of an identical-appearing placebo, or vice versa. Diaries were used to measure potential toxicities and hot flashes during the baseline week and the two subsequent 4-week treatment periods. RESULTS: The 120 patients evaluated fortoxicity failed to show any. The 105 patients who finished the first treatment period showed a similar reduction in hot flash frequencies (25% v 22%; P = .90) for the two study arms. A crossover analysis, however, showed that vitamin E was associated with a minimal decrease in hot flashes (one less hot flash per day than was seen with a placebo) (P < or = .05). At the study end, patients did not prefer vitamin E over the placebo (32% v 29%, respectively). CONCLUSION: Although this trial was able to show a statistically significant hot flash reduction with vitamin E compared to a placebo, the clinical magnitude of this reduction was marginal.
RCT Entities:
PURPOSE: Hot flashes represent a substantial clinical problem for some breast cancer survivors. Although estrogen or progesterone preparations can alleviate these symptoms in many patients, concern remains regarding the use of hormonal preparations in such women. Thus, there is a perceived need for nonhormonal treatments for hot flashes for breast cancer survivors. Based on anecdotal evidence that vitamin E was helpful, we designed a trial to investigate this matter. METHODS: We developed and conducted a placebo-controlled, randomized, crossover trial where, after a 1 week baseline period, patients received 4 weeks of vitamin E 800 IU daily, then 4 weeks of an identical-appearing placebo, or vice versa. Diaries were used to measure potential toxicities and hot flashes during the baseline week and the two subsequent 4-week treatment periods. RESULTS: The 120 patients evaluated for toxicity failed to show any. The 105 patients who finished the first treatment period showed a similar reduction in hot flash frequencies (25% v 22%; P = .90) for the two study arms. A crossover analysis, however, showed that vitamin E was associated with a minimal decrease in hot flashes (one less hot flash per day than was seen with a placebo) (P < or = .05). At the study end, patients did not prefer vitamin E over the placebo (32% v 29%, respectively). CONCLUSION: Although this trial was able to show a statistically significant hot flash reduction with vitamin E compared to a placebo, the clinical magnitude of this reduction was marginal.
Authors: Brian Hutton; Mona Hersi; Wei Cheng; Misty Pratt; Pauline Barbeau; Sasha Mazzarello; Nadera Ahmadzai; Becky Skidmore; Scott C Morgan; Louise Bordeleau; Pamela K Ginex; Behnam Sadeghirad; Rebecca L Morgan; Katherine Marie Cole; Mark Clemons Journal: Oncol Nurs Forum Date: 2020-07-01 Impact factor: 2.172
Authors: Heather Greenlee; Melissa J DuPont-Reyes; Lynda G Balneaves; Linda E Carlson; Misha R Cohen; Gary Deng; Jillian A Johnson; Matthew Mumber; Dugald Seely; Suzanna M Zick; Lindsay M Boyce; Debu Tripathy Journal: CA Cancer J Clin Date: 2017-04-24 Impact factor: 508.702
Authors: Charles L Loprinzi; Rui Qin; Ernie P Balcueva; Ernie P Baclueva; Kathleen A Flynn; Kendrith M Rowland; David L Graham; Nancy K Erwin; Shaker R Dakhil; Donald J Jurgens; Kelli N Burger Journal: J Clin Oncol Date: 2009-11-09 Impact factor: 44.544