cervical cancer
Conditions
Interventions
experimental group:vaginal douching with recombinant human superoxide dismutase
control group:vaginal douching with normal saline
Sponsors
Peking University Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1: Patients are fully voluntary and self-directed, signing an informed consent for the study within 30 days prior to enrollment 2: Age >= 18 and =1.5*10^9/L, HGB>=80g/L, PLT>=100*10^9/L, creatinine < 1.5mg/dl (133umol/L), AST and ALT <=2ULN.
Exclusion criteria
Exclusion criteria: 1: Prior history of allergy to recombinant human superoxide dismutase 2: Patients with skin and mucous membrane infections, obvious uterine pus or pelvic inflammatory disease 3: Patients who have undergone surgery (including pelvic or retroperitoneal lymph node dissection, excluding tumor biopsy), radiation therapy or chemotherapy for cervical cancer 4: Those who are not expected to be able to undergo brachytherapy, or whose brachytherapy requires the use of an aneurysm curettage, separate placement of uterine tubes and foramen ovale tubes, or a template program 5: History of other malignant tumors 6: Pregnant or lactating women 7: With active infection, fever 8: Other serious medical conditions that may significantly affect compliance with clinical trials, such as unstable heart disease requiring treatment, kidney disease, chronic hepatitis, poorly controlled diabetes, and psychiatric disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of acute and chronic vaginal injuries in patients within 2 years from the start to the end of radiation therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| >=Incidence of grade >=2 acute and chronic vaginal injuries in patients within 2 years from the start to the end of radiation therapy;Vaginal flora diversity;2-year OS, 2-year PFS;Quality of life before, during and after radiotherapy; | — |
Countries
China
Contacts
Public ContactXiaofan Li
Peking University Cancer Hospital
Outcome results
None listed