Traditional Chinese medicine for the management of aromatase inhibitor-associated musculoskeletal symptoms
| ISRCTN | ISRCTN06129599 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06129599 |
| Secondary identifying numbers | D131100002213001 |
- Submission date
- 24/07/2013
- Registration date
- 14/08/2013
- Last edited
- 25/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
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
Contact information
Scientific
No.23, Back Road of Gallery, Dong Cheng District, Beijing, China
Beijing
100010
China
Study information
| Study design | Multicentre randomised double-blinded placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomized, double-blinded, placebo-controlled trial of traditional Chinese Medicine for the management of aromatase inhibitor-associated musculoskeletal symptoms |
| Study objectives | The purpose of this study is to determine whether traditional Chinese medicine is effective in managing aromatase inhibitor-associated musculoskeletal symptoms. |
| Ethics approval(s) | Research Ethical Committee of the Beijing Hospital of Traditional Chinese Medicine, 22/04/2013, ref: 201337 |
| Health condition(s) or problem(s) studied | Aromatase inhibitor-associated musculoskeletal symptoms |
| Intervention | The 84 eligible participants are randomly allocated to two different groups: 1. Treatment group: Calcium carbonate and vitamin D3 tablets (Ca 600mg+ vitD3 125IU per tablet, 2 tablets per day) twice a day for 3 months, Chinese medicine granules (12.375g granules per bag, 2 bags per day) twice a day for 3 months. 2. Control group: Calcium carbonate and vitamin D3 tablets (Ca 600mg+ vitD3 125IU per tablet, 2 tablets per day) twice a day for 3 months, placebo granules (12.375g granules per bag, 2 bags per day) twice a day for 3 months. The patients receive assessments every month during the treatment and the third month after the treatment. |
| Intervention type | Other |
| Primary outcome measure | 1. The Brief Pain Inventory-Short Form (BPI-SF) to evaluate general pain 2. Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index to assess joint pain, stiffness, and functional status in the knees. 3. The Modified Score for the Assessment and quantification of Chronic Rheumatoid Affections fo the hands (M-SACRAH) to assess joint pain, stiffness, and functional status in the hands. The outcome measures above will be assessed before the treatment, at 1 month, 2 and 3 months during the treatment, the assessments will be repeated at the third month after the treatment. |
| Secondary outcome measures | 1. The Functional Assessment of Cancer Therapy breast cancer-specific quality of life tool (FACT-B) to evaluate quality of life of patients with breast cancer. 2. TCM symptoms scale to evaluate TCM syndrome (deficiency of liver and kidney, qi and collaterals stagnation). 3. Bone Mineral Density (BMD) to evaluate bone density and bone metabolism objectively 4. Bone Metabolic Markers (calcium, phosphorus, alkaline phosphatase, osteocalcin, calcitonin) to evaluate bone density and bone metabolism objectively FACT-B and TCM syndrome will be assessed before the treatment, at 1 month, 2 and 3 months during the treatment, the assessments will be repeated at the third month after the treatment. BMD and bone metabolic markers will be assessed before and after the treatment. |
| Overall study start date | 01/08/2013 |
| Completion date | 31/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 84 |
| Key inclusion criteria | 1. Stage I-III breast cancer with no evidence of recurrence and metastasis, completed chemotherapy and/or radiotherapy 2. Use of a third-generation aromatase inhibitor (AI) and self-report ongoing musculoskeletal symptoms after initiation of aromatase inhibitor (AI) therapy 3. A baseline worst pain score over the past week on the Brief Pain Inventory-Short Form (BPI-SF) of ≥3 points on a scale of 0 to 10 4. Traditional Chinese Medicine (TCM) syndrome is differentiated as deficiency of liver and kidney, qi and collaterals stagnation 5. Anticipated survival time is more than six months 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 7. All patients provided written informed consent before enrollment |
| Key exclusion criteria | 1. Patients with endocrine and any other diseases influencing bone metabolism (hyperthyroidism, hypothyroidism, diabetes, chusing syndrome, chronic liver disease, nephropathy, myeloma, bone tumor, bone metastasis) 2. Use of the agents influencing bone metabolism (glucocorticoid, thyroid hormone, heparin, anticonvulsant, diuretic, bisphosphonates) except calcium within the past three months 3. Contraindication in calcium agent and vitamin D 4. Diagnosis of primary osteoarticular diseases 5. Complicated with other primary tumors and serious heart, liver, kidney and hematopoietic system diseases 6. Pregnancy, mental illness and cognitive handicap |
| Date of first enrolment | 01/08/2013 |
| Date of final enrolment | 31/12/2015 |
Locations
Countries of recruitment
- China
Study participating centre
100010
China
Sponsor information
Government
No.16 Xizhimen South Street
Xi Cheng District
Beijing
100035
China
"ROR" |
https://ror.org/034k14f91 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | As of August 2017 results have been accepted for publication in The Breast. |
| IPD sharing plan | The datasets and analysis will be included in the results publication. For any questions, contact elva_pn@163.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 15/05/2014 | Yes | No | |
| Results article | results | 01/02/2018 | Yes | No |
Editorial Notes
25/10/2017: Publication reference added.
14/08/2017: IPD statement added.
