Using stem cells to support chemotherapy for ovarian cancer
Conventional Dose Chemotherapy for Ovarian Cancer Supported by Autologous Haematopoietic Stem Cell Transfusion
This study is testing if using a patient's own stem cells after chemotherapy can help women with ovarian cancer recover their bone marrow function faster and better than chemotherapy alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Chongqing University Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT05401162 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of autologous hematopoietic stem cell transfusion in supporting the recovery of bone marrow function after chemotherapy in patients with ovarian cancer. Participants are divided into two groups: one receiving conventional chemotherapy alone and the other receiving chemotherapy followed by stem cell transfusion. The primary endpoints include the incidence and duration of severe neutropenia and the time taken for hematopoietic recovery. Secondary endpoints assess chemotherapy dose adjustments, incidence of febrile neutropenia, and the safety of the stem cell reinfusion therapy.
Who should consider this trial
Good fit: Ideal candidates are pre-menopausal women aged 18-60 with histopathologically confirmed ovarian cancer who are undergoing chemotherapy.
Not a fit: Patients with bone marrow diseases or those with central nervous system involvement may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery from chemotherapy and improve overall treatment outcomes for ovarian cancer patients.
How similar studies have performed: While the use of stem cells in conjunction with chemotherapy is a recognized approach, this specific application in ovarian cancer is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1）18-60 years old; 2)there are chemotherapy indicators for ovarian cancer;3)ovarian cancer diagnosed by histopathology;4)recurrent and metastatic ovarian cancer;5)the Eastern Cooperative Oncology Group (ECOG) performance status score≤1;6)the expected survival time was more than 3 months; 7)pre-menopausal women (post-menopausal women must have been postmenopausal for at least 12 months to be considered infertile), and the serum pregnancy test results are negative;8)all patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment;9)the subjects voluntarily participate in this clinical trial sign an informed consent form and are able to complete the study procedures and follow-up examinations;10)bone marrow function is good,ability to perform stem cell mobilisation and collection. Exclusion Criteria: 1\) patients with bone marrow disease;2)central nervous system or soft meningeal or bone or bone marrow metastases confirmed by imaging or pathology;3)patient has severe cardiac insufficiency;4)previous history of allogeneic stem cell transplantation or organ transplantation;5)patients with active bleeding and autoimmune thrombocytopenic purpura;6)patients with chemotherapy contraindications;7)positive for human immunodeficiency virus (HIV);8)acute or chronic active hepatitis B or hepatitis C infection.
Where this trial is running
Chongqing, Chongqing Municipality
- Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Dongling Zou, M.D. — Chongqing University Cancer Hospital
- Study coordinator: Dongling Zou, M.D.
- Email: cqzl_zdl@163.com
- Phone: 13657690699
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.