Chronic radiation-induced cystitis in cervical cancer
Conditions
Interventions
Control Group:Recombinant human granulocyte-macrophage colony-stimulating factor (400 µg) dissolved in 5 mL of normal saline, administered via intravesical instillation twice daily for 5 consecutive d
Experimental Group:Recombinant human granulocyte-macrophage colony-stimulating factor (400 µg) dissolved in 5 mL of normal saline, administered into the bladder twice daily for 5 consecutive days + Po
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Conform to the diagnostic criteria of Western medicine, with a pathological diagnosis of cervical cancer, having undergone pelvic radiotherapy, with at least 3 months since the completion of radiotherapy, and meeting the grading criteria for RTOG/EORTC late radiation-induced bladder injury grade 2 or above; 2. Conform to the diagnostic criteria of Traditional Chinese Medicine (TCM), with TCM differentiation of "heat accumulation with yin injury, water retention and blood stasis"; 3. Voluntarily signed the informed consent form; 4. Age between 18 and 70 years old (inclusive); 5. Liver and kidney function and hematopoietic function meet the following criteria (without ongoing supportive therapy): - Neutrophils > 1.5×109/L, - Platelets > 100×109/L, - Hemoglobin > 8.0 g/dL; - Total bilirubin normal or <1.5×ULN; - AST (SGOT), ALT (SGPT) <2.5×ULN; - Serum creatinine <1.5×ULN; 6. Estimated survival=6 months; 7. KPS score =80 points.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women; 2. Individuals allergic to the investigational drug or its excipients; 3. Patients with any clinically significant diseases, including but not limited to neurological, cardiovascular, hematological and lymphatic, immune, renal, hepatic, respiratory, metabolic, and skeletal system diseases, or with uncontrolled severe infections, moderate to severe coagulation disorders, or significant bleeding tendencies; 4. Patients with other urinary system diseases: other conditions that can cause symptoms such as urinary frequency, urgency, difficulty in urination, or hematuria, including bladder cancer or other cancers infiltrating the bladder, bladder stones, ureteral stones, glomerulonephritis, interstitial cystitis, etc., confirmed by relevant examinations (e.g., cystoscopy, ultrasound, CT, renal function tests, etc.); 5. Patients who have participated in other drug or medical device clinical trials within the past 4 weeks; 6. Patients with radiation cystitis, bladder stenosis, even obstruction, severe bleeding, and fistula formation requiring surgical treatment; 7. Severe urinary tract diseases that cannot tolerate intravesical administration; 8. Patients deemed unsuitable for participation in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy rate based on LENT-SOMA score; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM Syndrome Efficacy and TCM Single Symptom Efficacy;Quality of Life Scale;Inflammatory Factors;Inflammatory Factors;Urinalysis;Adverse reaction incidence rate; | — |
Countries
China
Contacts
Public ContactWu Heng Ke, Zou Dong Ling
Chongqing University Cancer Hospital
Outcome results
None listed