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Randomized double blind clinical study of Shugan Yishen in prevention and treatment of osteoporosis in postmenopausal patients with estrogen receptor positive breast cancer

Randomized double blind clinical study of Shugan Yishen in prevention and treatment of osteoporosis in postmenopausal patients with estrogen receptor positive breast cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042640
Enrollment
Unknown
Registered
2021-01-24
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-05-10

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

Conditions

Estrogen receptor-positive breast cancer

Interventions

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Breast cancer patients with previous postoperative histopathological diagnosis and tumor staging between Stage I and III, but not stage IV; 2. The patient is already in the postmenopausal state; 3. Postoperatively, 4. Immunohistochemical patients were ER positive or PR positive and HER2 negative. 5. Patients aged between 45 and 80 years; 6. Physical condition score KPS >= 80, and the expected survival time is more than 1 year. 7. No obvious dysfunction of important organs such as heart, lung, liver and kidney. White blood cells >= 4.0 x 10^9/L; For granulogram count >= 2.0 x 10^9/L, hemoglobin >= 10g/L, total bilirubin <= 30 mol/L, alanine aminotransferase <= 40 u /L, alanine aminotransferase <= 40U/L, creatinine <= 130 mg/dl, urea nitrogen <= 7.14mmol/L; 8. Meet the diagnostic criteria of osteopenia and osteoporosis; 9. Is taking letrozole, anastrozole and exemestane, one of the endocrine drugs; 10. Syndrome differentiation of TCM belongs to liver depression and spleen deficiency syndrome.

Exclusion criteria

Exclusion criteria: 1. Allergic to letrozole, anastrozole and exemestane; 2. The patient has uncontrolled infection or severe medical disease; 3. Those with tumor invasion of the brain and not effectively controlled; 4. Those who fail to use the medicine according to the regulations and the incomplete data affect the judgment of curative effect.

Design outcomes

Primary

MeasureTime frame
Bone density;progression-free survival;tumor marker;

Secondary

MeasureTime frame
Immunity;traditional Chinese medicine symptom;

Countries

China

Contacts

Public ContactZhu Weikang

Shanghai Municipal Hospital of Traditional Chinese Medicine

zhuweikang@vip.163.com+86 13818186762

Outcome results

None listed

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