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Randomized clinical study on evaluation of Kangfuxin liquid in the prevention and treatment of cervical cancer radiation enteritis

Randomized clinical study on evaluation of Kangfuxin liquid in the prevention and treatment of cervical cancer radiation enteritis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055355
Enrollment
Unknown
Registered
2022-01-08
Start date
2022-01-01
Completion date
Unknown
Last updated
2023-01-30

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

Conditions

Cervical cancer

Interventions

Experimental group:Kangfuxin liquid
Control group:None

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with cervical cancer first diagnosed by pathology; 2. Patients with stage IB-IV (2019 FIGO stage) requiring radiotherapy; 3. Aged 18-70 years; 4. Have not received pelvic radiotherapy before enrollment; 5. ECOG general condition score 0-2; 6. The expected survival period is more than 12 months; 7. Laboratory tests before radiotherapy and chemotherapy meet the following conditions: (1) Liver function: total bilirubin = 80 mL/min; (3) Blood function: absolute neutrophil count (ANC) >=2x10^9/L, platelet count >=100x10^9/L and hemoglobin >=9g/dL; 8. Agree and sign the informed consent form (if the patient himself has no judgment ability, his legal guardian is required to sign the informed consent form).

Exclusion criteria

Exclusion criteria: 1. History of rectal-related surgery in the past; 2. The tumor was found to have rectal invasion before treatment; 3. Patients who are pregnant or breastfeeding; 4. Those with recurrent proctitis before radiotherapy (more than 1 time/month); 5. Patients with Crohn's disease and ulcerative colitis; 6. At the same time receiving experimental treatments of other clinical studies (in the treatment period of clinical studies or participating in clinical trials of other drugs within 30 days); 7. Elderly patients with dry stomatitis; 8. Those with severe heart, lung, liver and kidney dysfunction, such as decompensated heart, lung, kidney, liver and other major organ dysfunction and failure, cannot tolerate radiotherapy; 9. Inability to take orally or absorb drugs through the digestive tract; 10. There are factors affecting administration, distribution, metabolism, excretion, etc., such as mental disorders, central nervous system disorders, chronic diarrhea, ascites, pleural effusion, etc.; 11. Long-term use of immunosuppressive agents or combined use of immunosuppressive agents after organ transplantation; 12. Those who have a history of other malignant tumors before enrollment and those who have a history of other malignant tumors at the same time; 13. Patients with cognitive impairment, or poor compliance with radiotherapy and chemotherapy as judged by the investigator; 14. Those who are deemed inappropriate by the investigator to conduct clinical trials.

Design outcomes

Primary

MeasureTime frame
Number of stools;

Countries

China

Contacts

Public ContactYang Xiaojing

Shanghai Sixth People's Hospital

yangxj717@163.com+86 21 24058972

Outcome results

None listed

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