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Clinical study of ShenlingBaizhu Powder for prevention of chemotherapy-related diarrhea in small cell lung cancer

Clinical study of ShenlingBaizhu Powder for prevention of chemotherapy-related diarrhea in small cell lung cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000272
Enrollment
Unknown
Registered
2025-02-15
Start date
2024-01-01
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Small cell lung cancer

Interventions

Treatment group:Shenling Baizhu powder +IP chemotherapy ± CRD Western standard treatment
Control group:IP protocol chemotherapy ± CRD Western standard treatment

Sponsors

Shenshan Medical Center Sun Yat-sen Memorial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Patients with extensive stage SCLC confirmed by pathology or cytology have at least one measurable lesion; 2)According to the CSCO guidelines chemotherapy regimen containing irinotecan was first used; 3)Age 18-80 years old (including 18 years old and 80 years old); 4) Physical condition (PS) score of 0-2 formulated by the American Eastern Cancer Collaborative Group (ECOG); 5) Expected survival =3 months; 6) Patients can understand the situation of this study can cooperate with doctors to evaluate diarrhea grading have good compliance and are willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients with primary malignant tumors of other systems or organs; 2) Confirmed combination of primary diseases causing diarrhea (such as acute and chronic enteritis inflammatory bowel disease etc.) radiation enteritis or long-term use of laxative drugs; 3) Received pelvic radiotherapy in the last 2 weeks; 4) Patients with severe uncontrolled organic disease or infection such as decompensated heart lung renal failure etc. resulting in inability to tolerate chemotherapy; 5) Pregnant or lactating women; 6) Participants in other clinical trials currently or within 4 weeks; 7)A significant neurological and psychiatric history including dementia that may affect comprehension and informed consent.

Design outcomes

Primary

MeasureTime frame
Incidence of diarrhea;

Secondary

MeasureTime frame
Evaluation of chemotherapy effect;Rate of change in chemotherapy plan;Degree of diarrhea;

Countries

CHINA

Contacts

Public ContactXiao Haiwei

Shenshan Medical Center Sun Yat-sen Memorial Hospital

xhaiwei@foxmail.com+8617520430523

Outcome results

None listed

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