Moxibustion combined with herbs for the prophylactic and therapeutic use of joint pain caused by aromatase inhibitors in postmenopausal breast cancer: a randomized controlled trial

Phase 1

Recruiting

• Conditions: Breast Cancer

• Registration Number: ITMCTR2000003768
• Lead Sponsor: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of TCM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. All patients were meet the pattern identification criteria of TCM and diagnostic criteria of western medicine;
2. Patients must be postmenopausal female;
3. Aged from 45 to 75 years;
4. Pathological investigations confirmed a primary invasive breast cancer;
5. According to the pathological results and the physical condition, all patients were required to take AI with breast cancer guidelines of CBCSG (version 2019);
6. Patients who have taken AI for at least three months ;
7. Patients who have joint pains during taking AI and the score about BPI-SF > 4;
8. Be willing to participate in clinical trials and be able to cooperate with regular follow-up;
9. All patients must have signed and dated an informed consent form.

Exclusion Criteria

1. Recurrent and metastatic breast cancer;
2. Severe liver and kidney dysfunction (AST/SGOT or ALT/AGPT is > 2.5 times of the ULN, and Serum Cr is >= 150umol/L);
3. Severe heart dysfunction other organ failure;
4. Any previous or concurrent primary malignancy;
5. A history of fracture or joint surgery within 6 months;
6. Patients who had used traditional Chinese medicine, moxibustion treatment or other TCM related treatment for AIA in the past 3 months;
7. Participating in other clinical trials within 3 months;
8. In any reason that cannot cooperate with the study, such as language understanding, unable to refer to the research center, etc.;
9. Other conditions or diseases that may be excluded from the study that may result in significant risk or confusion in the study;
10. Previous use of NSAIDs and opioid analgesics.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bone metabolism;BPI;BMP;

Secondary Outcome Measures

Name	Time	Method
electrolytes (Ca, P);WOMAC;sex hormone;To follow the 3-year, 5-year, 10-year disease free survival and overall survival;