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Study on the application and mechanism of Jianpi-Bushen Sanjie recipe in improving immune imbalance in breast cancer patients after chemotherapy

Study on the application and mechanism of Jianpi-Bushen Sanjie recipe in improving immune imbalance in breast cancer patients after chemotherapy

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071285
Enrollment
Unknown
Registered
2023-05-10
Start date
2023-05-20
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Immune imbalance after chemotherapy for breast cancer

Interventions

Cinese medicine group:Jianpi-Bushen Sanjie recipe
Control group:Regular anti-tumor treatment

Sponsors

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Women with stage I-IIIA breast cancer who meet the above diagnostic criteria of Western medicine and Chinese medicine and are confirmed by clinical and cytology or pathology; Immune imbalance existed in the baseline period; Aged 18-70 years; 2. After radical surgery, the observation period was less than 6 months from the end of radiotherapy and chemotherapy, and no tumor recurrence or metastasis was detected; 3. No history of other malignant tumors, no other diseases that damage or affect immune function; 4. No immunotherapy drugs were used; Did not receive immunotherapy; 5. General KPS (Karnofsky) score >=60 points; 6. No anemia or hypoproteinemia; 7. The required observation content is recorded completely; 8. Be able to understand the purpose and requirements of the study, and voluntarily sign the informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating patients; 2. Complicated with cardio-cerebrovascular, liver, kidney, hematopoietic system and other serious primary diseases or serious diseases that seriously affect their survival; 3. Patients who have received antibiotics or probiotics within the past 1 month; 4. Have a known bacterial, fungal or viral infection.

Design outcomes

Primary

MeasureTime frame
Functional analysis of immune cells;

Secondary

MeasureTime frame
Quality of life;Safety evaluation;

Countries

China

Contacts

Public ContactYao Yandan

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

yaoyand@mail.sysu.edu.cn+86 138 2629 2688

Outcome results

None listed

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