NCT05401162

Chemotherapy Supported by Autologous Hematopoietic Stem Cells

Conventional Dose Chemotherapy for Ovarian Cancer Supported by Autologous Haematopoietic Stem Cell Transfusion

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Chongqing University Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The aim of this project is to use autologous haematopoietic stem cell transfusion support to promote the reconstruction of haematopoietic function after chemotherapy for ovarian cancer. To explore the impact of stored haematopoietic stem cell support therapy on bone marrow protection after conventional chemotherapy for ovarian cancer in order to facilitate its clinical application.

Detailed description

Study design:In this prospective, single-center,non-randomised controlled study, patients with ovarian cancer were divided into two groups. The patients in the experimental group received autologous blood transfusion containing hematopoietic stem cells 1 day after conventional chemotherapy, while the control group only received conventional chemotherapy. Case selection: Patients with primary ovarian cancer,ovarian cancer confirmed by histopathology, and three weeks of platinum-containing regimen chemotherapy. Primary end point: 1)incidence and duration of grade 3/4 neutropenia in patients;2)hematopoietic reconstitution time in patients. Secondary endpoints: 1)the rate of reduction in chemotherapy dose and postponement of the course for chemotherapy;2) Incidence of febrile neutropenia (FN);3)Safety of hematopoietic stem cell reinfusion therapy (adverse events). Safety assessment: laboratory safety testing, including platelet count,white blood cell and hemoglobin. Evaluation of adverse events: infection, neutropenic fever, hypocalcemia,anemia and thrombocytopenia,bone pain, etc.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
OTHER	Autologous blood transfusion with haematopoietic stem cells	Transfusion of autologous blood containing haematopoietic stem cells for haematopoietic reconstruction after chemotherapy.Blood tests were performed weekly, if the patient's neutrophils were less than 1.0 × 109 / L during chemotherapy, G-CSF was given as a remedial treatment. If fever occurs, antibiotics were given promptly.Monitor peripheral blood after transfusion. If peripheral blood leukocyte count does not reach 1.0 x 109/L, administer G-CSF 150 μg subcutaneously daily until peripheral blood leukocyte count reaches 1.0 x 109/L.Patients were tested monthly for peripheral blood cells for 6 months after the end of treatment.

Timeline

• Start date: 2022-04-15
• Primary completion: 2025-05-01
• Completion: 2027-05-01
• First posted: 2022-06-02
• Last updated: 2022-06-02

Locations

1 site across 1 country: China