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Clinical Trials/ISRCTN06129599
ISRCTN06129599
Completed
未知

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

Beijing Municipal Science and Technology Commission (China)0 sites84 target enrollmentAugust 14, 2013
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Beijing Municipal Science and Technology Commission (China)
Enrollment
84
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 14, 2013
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Beijing Municipal Science and Technology Commission (China)

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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