Condition category
Signs and Symptoms
Date applied
24/07/2013
Date assigned
14/08/2013
Last edited
03/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Xiaomin Wang

ORCID ID

Contact details

No.23
Back Road of Gallery
Dong Cheng District
Beijing
China
Beijing
100010
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

D131100002213001

Study information

Scientific title

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

Acronym

Study hypothesis

The purpose of this study is to determine whether traditional Chinese medicine is effective in managing aromatase inhibitor-associated musculoskeletal symptoms.

Ethics approval

Research Ethical Committee of the Beijing Hospital of Traditional Chinese Medicine, 22/04/2013, ref: 201337

Study design

Multicentre randomised double-blinded placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/08/2013

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

84

Participant 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

Recruitment start date

01/08/2013

Recruitment end date

31/12/2015

Locations

Countries of recruitment

China

Trial participating centre

No.23, Back Road of Gallery, Dong Cheng District, Beijing, China
Beijing
100010
China

Sponsor information

Organisation

Beijing Municipal Science and Technology Commission (China)

Sponsor details

No.16 Xizhimen South Street
Xi Cheng District
Beijing
100035
China

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Beijing Municipal Science and Technology Commission (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24885324

Publication citations

  1. Protocol

    Peng N, Zhang Y, Ma C, Yu MW, Yang GW, Fu Q, Xu WR, Wang XM, Effects of the traditional Chinese medicine Yi Shen Jian Gu granules on aromatase inhibitor-associated musculoskeletal symptoms: a study protocol for a multicenter, randomized, controlled clinical trial., Trials, 2014, 15, 171, doi: 10.1186/1745-6215-15-171.

Additional files

Editorial Notes