Randomized, double-blinded, placebo-controlled trial of traditional Chinese Medicine for the management of aromatase inhibitor-associated musculoskeletal symptoms View Homepage


Ontology type: schema:MedicalStudy     


Clinical Trial Info

YEARS

2013-2015

ABSTRACT

Background and study aims Women with breast cancer treated with a type of drug called aromatase inhibitors (AIs) may experience symptoms affecting muscles and bones that can lead to treatment having to be stopped. It is important to find a safe and effective treatment strategy to manage these symptoms. The purpose of this study is to find out how well traditional Chinese medicine (TCM) works for the management of aromatase inhibitor-associated musculoskeletal symptoms and its safety. Who can participate? Women with a history of stage I to III breast cancer who are currently taking a third-generation AI and have ongoing symptoms affecting bones and muscles, which started or worsened after initiation of AI therapy, can participate in the study. What does the study involve? Participants are randomly allocated to one of two groups: the treatment group and the control group. Women in the treatment group will receive calcium, vitamin D3 and TCM granules. The control group will be given calcium, vitamin D3 and placebo (dummy) granules. Participants will complete questionnaires at the start of the study and every month after that to find out about changes in pain, movement and quality of life. Participants will undergo certain tests before and after treatment in order to find out the safety and effectiveness. Participants will be followed up after three months to assess long-term effectiveness. What are the possible benefits and risks of participating? All participants will receive free treatment for 3 months and a series of free tests. The symptoms of the bones and muscles could be relieved. The result of this study may help to provide evidence that traditional Chinese medicine is safe and effective. You have to visit hospital regularly, which may be inconvenient and may disturb your routine. You will have some mild side effects when you start taking TCM granules, such as nausea. That will resolve gradually as you adapt to the smell and taste of TCM. Where is the study run from? The study is run from three locations: 1. Beijing Hospital of Traditional Chinese Medicine, China 2. Beijing Cancer Hospital, China 3. Guang' anmen Hospital, China Academy of Chinese Medical Sciences, China When is the study starting and how long is it expected to run for? The study will start in August 2013 and will end in December 2015. Who is funding the study? Beijing Municipal Science and Technology Commission (China) Who is the main contact? Dr Xiaomin Wang elva_pn@163.com More... »

URL

http://www.isrctn.com/ISRCTN06129599

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