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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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037192
Enrollment
Unknown
Registered
2020-08-27
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

Sponsors

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of TCM
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 75 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
BPI;bone metabolism;BMP;

Secondary

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

Countries

China

Contacts

Public ContactXiaohong Xue

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of TCM

xiaohong_xue0702@163.com+86 18930568130

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026