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Prospective cohort clinical study on Wenshen Zhuanggu recipe inhibiting bone metastasis of breast cancer by regulating exosomes

Prospective cohort clinical study on Wenshen Zhuanggu recipe inhibiting bone metastasis of breast cancer by regulating exosomes

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2026000761
Enrollment
Unknown
Registered
2026-03-27
Start date
2026-01-31
Completion date
Unknown
Last updated
2026-04-28

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

Conditions

Bone metastasis after breast cancer surgery

Interventions

Exposure group:Wenshen Zhuanggu Formula Combined with Western Medicine (Zoledronic Acid/Disuzumab)
Non-exposed group:Simple Western Medicine Treatment (Zoledronic Acid/Disuzumab)

Sponsors

Longhua Clinical Medical College affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Those who meet the following conditions shall be included: (1) It meets the diagnostic criteria of breast cancer and must be confirmed by pathology; (2) Bone metastases must be confirmed by whole body bone scanning (ECT), X-ray, CT, MRI or bone pathological biopsy; (3) There is no second primary tumor in the whole body; (4) All patients are female, aged =18 years and =70 years; (5)The required clinical data are complete, and the information of symptoms, signs and tongue and pulse in traditional Chinese medicine is complete enough for syndrome differentiation; (6)Physical condition Karnofsky>40 points, and it is expected to survive for more than 6 months; (7)The patient agrees and cooperates with the investigation;

Exclusion criteria

Exclusion criteria: Exclusion criteria: those who meet the selection criteria but meet one of the following conditions shall be excluded: (1) the diagnosis is not in line with breast cancer or without bone metastasis; (2) Patients with severe heart, liver, kidney, blood system, endocrine system dysfunction and mental illness; (3) Patients with other organ metastases; (4) The patient is accompanied by SREs; (5) The patient's clinical data is not perfect, or the information of the four diagnoses of traditional Chinese medicine is incomplete; (6) The patient does not cooperate; (7) Participated in clinical trials of other drugs within 12 weeks before screening.

Design outcomes

Primary

MeasureTime frame
Concise pain scale;Pain score by SF-MPQ method;

Secondary

MeasureTime frame
Evaluation of curative effect of bone metastases;Progressively free survival;Incidence rate of bone adverse events;Quality of life score;

Countries

China

Contacts

Public ContactChunyu Wu

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

xiaoyu9.05@163.com+86 13661860905

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026