Reducing Hot Flushes after Breast Cancer study
Chief Investigator: Professor Susan Davis
The aim of this study is to assess a new non hormonal compound called Q-122 for hot flushes and/or night sweats in women with breast cancer on tamoxifen or aromatase inhibitor (AI) therapy.
Hot flushes and night sweats are the hallmark of menopause and are due to the drop in estrogen at menopause. As tamoxifen and aromatase inhibitors block estrogen production these medications can either cause or increase the frequency and severity of hot flushes and night sweats. Standard therapy for hot flushes and night sweats is hormone replacement therapy; however, this is considered unsafe for women who have had breast cancer as it can increase the risk of the cancer returning. Q-122 is not a hormone and does not act on hormone receptors.
For this study we will recruit 15 women with breast cancer on aromatase inhibitor therapy (anastrozole, letrozole, exmestane) or tamoxifen. Half of the women will use active medication and half will be the control group using placebo (inactive medication).
Women will need to be able to:
- attend 6 visits over 9-10 weeks to the Women’s Health Research Program at 553 St Kilda Rd, Melbourne, 3004 Victoria
- have blood taken at each visit, and a urine test and ECG at the beginning and end of the study
- answer 4 questionnaires at each visit
- fill in an electronic diary at home
This research study is being conducted, sponsored, and funded by QUE Oncology Pty Limited. The study has been approved by Belberry Human Research Ethics Committee.