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Prophylaxis and Treatment of Chemotherapy-related Diarrhea with Shengjiang Xiexin Decoction in Lung Cancer Patients: A Multicenter Randomized Controlled Clinical Study

Prophylaxis and Treatment of Chemotherapy-related Diarrhea with Shengjiang Xiexin Decoction in Lung Cancer Patients: A Multicenter Randomized Controlled Clinical Study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018490
Enrollment
Unknown
Registered
2018-09-20
Start date
2018-10-01
Completion date
Unknown
Last updated
2018-09-24

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

Conditions

Chemotherapy-related Diarrhea

Interventions

TCM group:Shengjiang Xiexin Decotion

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. patients with small cell lung cancer diagnosed by pathology; 2. according to the NCCN guideline, was first used to treat the chemotherapy regimen containing irinotecan; 3. No chemotherapy for 3 months before entering group 4. Aged 18 to 80 years; 5. ECOG score: 0~2; 6. estimated survival period = 6 months; 7. no major organ dysfunction, heart, liver, kidney function is normal, laboratory indicators to achieve the following requirements:neutrophils>1.5x109/l,platelet>100x109/l, hemoglobin >90g/l; bilirubin is normal or < 1.5 x ULN ;AST, ALT<2.5xuln Serum creatinine <1.5xuln, endogenous creatinine clearance (CCR) =60 ml/min (calculated using the Cockcroft-gault formula); 8. able to understand the situation of this study, be able to coordinate with the assessment of diarrhoea grading, and have signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. diagnosed with diarrhea caused by the original disease (such as acute and chronic enteritis, inflammatory bowel disease, etc.), radioactive enteritis or long-term use of laxative drugs; 2. received pelvic radiotherapy in the last 2 weeks. 3. has serious, uncontrolled organic lesions or infections, such as decompensated heart, lung, kidney failure and other patients can not tolerate chemotherapy; 4. pregnant or lactating women; 5. Currently or within 4 weeks of participating in other clinical trials; 6. a clear neurological and psychiatric history, including dementia that may affect understanding and informed consent.

Design outcomes

Primary

MeasureTime frame
Incidence of diarrhoea;The degree of diarrhea;

Secondary

MeasureTime frame
Degree of neutrophil reduction;Change rate of chemotherapy plan;Evaluation of curative effect of chemotherap;overall survival;Progress-free survival;

Countries

China

Contacts

Public ContactJia Liqun

China-Japan Friendship Hospital

liqun-jia@hotmail.com+86 13601231765

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 18, 2026