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To investigate an open, randomized controlled clinical trial of recombinant human epidermal growth factor compound enema for the prevention and treatment of radiation proctitis caused by radical radiotherapy of cervical cancer

To investigate an open, randomized controlled clinical trial of recombinant human epidermal growth factor compound enema for the prevention and treatment of radiation proctitis caused by radical radiotherapy of cervical cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032874
Enrollment
Unknown
Registered
2020-05-14
Start date
2020-05-18
Completion date
Unknown
Last updated
2020-05-18

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

Conditions

cervical cancer

Interventions

Sponsors

Cancer Hospital Affiliated to Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed cervical cancer; 2. FIGO Clinical Stages IB1-IVa Patients with Primary Cervical Cancer; 3. Aged 18 -70 years and KPS more than 70 points; 4. Important organs function well before radiotherapy: white blood cell > 4.0 x 10^9 / L, neutrophils > 2.0 x 10^9 / L, hemoglobin > 90g / L, platelets > 100 x 10^9 / L, normal liver and kidney function: AST, ALT <2.5 times the upper limit of normal value, total bilirubin < 1.5 times the upper limit of normal value; serum creatinine value <upper limit of normal value; 5. Sign treatment informed consen; 6. Regular follow-up; 7. Ability to comply with experimental requirements.

Exclusion criteria

Exclusion criteria: 1. IVa stage patient with rectal involvement; 2. Severe rectal internal and external hemorrhoids cannot tolerate enema administration; 3. Previous history of gastrointestinal surgery; 4. History of allergy to any component of the tested drug; 5. Inflammatory bowel disease, irritable bowel syndrome, chronic gastrointestinal bleeding, and other diseases that may be associated with chronic diarrhea; 6. Special dietary preferences that can lead to intestinal symptoms and cannot be corrected; 7. Having personality or mental illness without civil conduct or limited capacity for civil conduct.

Design outcomes

Primary

MeasureTime frame
Incidence of Grade 2-4 Acute Radiation Proctitis;Subject Quality of Life Score (QLQ-C30);

Secondary

MeasureTime frame
Grade 2-4 acute radiation proctitis duration;Radiation therapy interruption time due to grade =3 acute radiation proctitis;

Countries

China

Contacts

Public ContactLi Mingyi

Cancer Hospital Affiliated to Guangzhou Medical University

venuslion80@163.com+86 13632325430

Outcome results

None listed

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