Efficacy and safety of a Chinese herbal medicine to reduce hot flushes/night sweats in women treated for breast cancer
Randomised, placebo-controlled, double-blind, cross-over, multi-centre study to evaluate the efficacy and safety of a Chinese herbal medicine (Shu Gan Liang Xue Decoction) to alleviate vasomotor symptoms in breast cancer survivors
Western Sydney University
84 participants
Jan 22, 2018
Interventional
Conditions
Summary
The aim of this study is to evaluate whether a Chinese herbal medicine (SGLXD) can reduce hot flushes/night sweats in women treated for breast cancer. Who is it for? You may eligible to join this study if you are a female aged 18 years or above and have been diagnosed with Stage 1-3 breast cancer, for which you have completed surgery, chemotherapy and/or radiotherapy and are experiencing hot flushes/night sweats. Trial details Participants in this study will be randomly allocated (by chance) to either group 1 or group 2 for 12 weeks of treatment. After this there is a 4-week period with no treatment then you are crossed-over to the other group for a further 12-week period. One 12 week treatment period will consist of two daily doses of the Chinese herbal medicine, Shu Gan Liang Xue Decoction dissolved in warm water and taken orally. The formula has been used at Beijing University Cancer Hospital by Professor Li and has been proven to be safe and effective in studies in China. During the other 12 week treatment period you will take an inactive placebo. Participants are required to undergo blood tests at 3 time points during the study and fill out a hot flush diary and quality of life forms. You are required to visit the hospital every 4 weeks to hand in the forms and receive 4-week supply of the treatment intervention. Pre-and post treatment differences in results of hot flush scores, quality of life scores and blood tests will be assessed between groups. Study results may contribute to achieving a novel intervention alternative therapeutic option to alleviate hot flushes and improve quality of life for Australian women treated for breast cancer.
Eligibility
Inclusion Criteria1
- Female, over 18 years, diagnosed with Stage 1-3 breast cancer, 2) completed surgery, chemotherapy and/or radiation. 3) If prescribed an estrogen-blocking medication i.e. tamoxifen or aromatase inhibitor stable for > 2 months prior to the study and unlikely to be changing estrogen-blocking medication during the study. 4) Protocol defined adequate hepatic and renal function. 5) Written informed consent.
Exclusion Criteria1
- Excluded if they have 1) poorly controlled hypertension, hypothyroidism or diabetes mellitus 2) hyperthyroidism 3) use of Hormone Replacement Therapy (HRT) - washout period 8 weeks 4)Unwilling to refrain from other remedies for hot flushes during study 5) pregnant or breast-feeding 9) use on blood-thinning medication 10) any other chronic condition deemed inappropriate by the clinician for the trial 11) Lack of, or withdrawal of informed consent. 12) Participation in another trial.
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Interventions
This study is a randomised controlled clinical trial with two parallel arms conducted under double-blind and placebo-controlled conditions on 84 participants aged 18 years or more, who have completed their acute stage of breast cancer treatment. One standard dose (10gr. in granule format) of Chinese herbal medicine, Shu Gan Liang Xue Decoction, dissolved in warm water and taken orally twice per day for 12 weeks, followed by a wash-out period of 4 weeks and then cross-over to the other arm of the trial. Participants will be asked to mark in their Hot Flush Daily Diary if they miss any doses and will return all unused doses at next visit.
Locations(3)
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ACTRN12617001247369