Effect of Sodium Thiosulfate on Nephrotoxicity of Cisplatin Intraperitoneal Heat-perfusion Chemotherapy

Trial Title: Effect of Sodium Thiosulfate on Nephrotoxicity of Cisplatin Intraperitoneal Heat-perfusion Chemotherapy

NCT ID: NCT05877911

Condition: Epithelial Ovarian Cancer
Acute Kidney Injury Due to Circulatory Failure

Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Acute Kidney Injury
Shock
Sodium sulfate

Conditions: Keywords:
Epithelial Ovarian Cancer
Acute Kidney Injury
Hyperthermic Intraperitoneal Chemotherapy
Sodium thiosulfate

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Patients were randomly assigned to treatment group or control group by block randomisation in a 1:1 ratio. Treatment group: Receive HIPEC using sodium thiouracil and hydration Control group: Receive HIPEC only using hydration.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Sodium Sulfate
Description: Sodium thiosulfate has previously been reported to reduce the incidence of acute kidney injury after HIPEC with cisplatin, but this finding has not been confirmed in a high-level study.
Arm group label: HIPEC with sodium thiosulfate and hydration

Intervention type: Other
Intervention name: Hydration
Description: On the day of surgery, the day of HIPEC, and 24 hours after HIPEC, daily intravenous rehydration should be performed using natrium chloride, glucose chloride or potassium chloride. The amount of fluid to be replenished should not be less than 3000 milliliters.
Arm group label: HIPEC with hydration only
Arm group label: HIPEC with sodium thiosulfate and hydration

Intervention type: Drug
Intervention name: Cisplatin
Description: Infuse cisplatin (75mg/m^2) at 43℃ through the two drainage tubes placed in the upper abdomen, using the two drainage tubes placed in the lower abdomen as the effluent tubes, with an infusion time of 60-90 minutes and an infusion rate of 500-600 mL/min. The first HIPEC should be performed within 24-48 hours after cytoreductive surgery. The second HIPEC should be performed 24 hours after the completion of the first HIPEC. Intravenous sedatives such as dexmedetomidine or propofol at 2-6 ml/h should be administered during HIPEC treatment with continuous intravenous infusion by a pump，or intramuscular injection of 50 mg of pethidine.
Arm group label: HIPEC with hydration only
Arm group label: HIPEC with sodium thiosulfate and hydration

Summary: Ovarian cancer is the most lethal malignancy of the female genital tract. Cytoreductive surgery combined with chemotherapy is the primary treatment for ovarian cancer, and radical tumor resection is an important means to improve the prognosis. However, even after complete tumor resection, 75% of patients with ovarian cancer still recur within 3 years after the initial treatment and eventually die from recurrence. In ovarian cancer, the lesions are located primarily in the peritoneal cavity. High-grade evidence demonstrates that the use of intraperitoneal hyperthermic chemotherapy (HIPEC) with cisplatin after cytoreductive surgery significantly improves the outcome in some patients with ovarian cancer. Currently, this is the only non-pharmacologic treatment that reduces both the risk of recurrence and death from ovarian cancer with a multi treatment. However, HIPEC with cisplatin can lead to acute kidney injury, and a serious complication that can seriously affect the short and long-term prognosis of patients. Sodium thiosulfate has previously been reported to reduce the incidence of acute kidney injury after HIPEC with cisplatin, but this finding has not been confirmed in a high-level study. Therefore, we propose a multi-center, prospective, open-label, randomized, controlled trial including 110 patients with ovarian cancer who received HIPEC with cisplatin, to evaluate whether sodium thiosulfate combined with hydration (55 patients in the trial group) can reduce the incidence of acute kidney injury after HIPEC with cisplatin compared with hydration alone (55 patients in the control group), and to provide high-level evidence for the rationale of using sodium thiosulfate for nephrotoxicity relief in cisplatin HIPEC.

Criteria for eligibility:
Criteria:
Inclusion Criteria:（The following conditions must be met at the same time） - Patients treated with HIPEC with cisplatin. - Estimated survival > 12 weeks - Age from 18 to 70 years - Bone marrow reserve was well functioning. Leukocytosis ≥ 3.0×10^9/L, neutrophilic granulocyte ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L, and hemoglobin ≥ 80 g/L. - Organs work well. AST ≤ 2.5 × ULN, ALT ≤ 2.5 × upper limit of normal(ULN), total serum bilirubin ≤ 1.5 × ULN, and creatinine ≤ 1.5 × ULN - ECOG score 0-1 - Patients voluntarily sign an informed consent form Exclusion Criteria:（None of which was eligible）. - Extensive abdominal adhesions - HIPEC with Cisplatin for other medical conditions in the last 5 years. - Receiving other drugs that cause kidney damage. - Simultaneous use of amifotin for other diseases. - Any situation of disease instability or potentially impact safety and adherence of patient. - Chronic or acute nephropathy of any degree or other serious medical complications.

Gender: Female

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Start date: May 2023

Completion date: April 2025

Lead sponsor:
Agency: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class: Other

Collaborator:
Agency: Yunnan Cancer Hospital
Agency class: Other

Collaborator:
Agency: Qilu Hospital of Shandong University
Agency class: Other

Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05877911