Hematopoietic Stem Cell-containing Autologous Blood Transfusion for Bone Marrow Protection in Patients With Cervical Cancer

NCT05401175RecruitingNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Chongqing University Cancer Hospital

Enrollment

40

Start Date

2022-04-13

Completion Date

2025-04-01

Study Type

INTERVENTIONAL

Official Title

Stored Hematopoietic Stem Cell-containing Autologous Blood Transfusion Therapy for Bone Marrow Protection in Patients With Cervical Cancer Treated With Concurrent Chemoradiotherapy

Interventions

Autologous blood transfusion with haematopoietic stem cells

Conditions

Cervical Cancer

Eligibility

Age Range

18 Years – 60 Years

Sex

FEMALE

Inclusion Criteria:

1)18-60 years old; 2)there are radiotherapy and chemotherapy indicators for cervical cancer;3)pathological diagnosis of squamous, adenocarcinoma or adenosquamous carcinoma;4)the Eastern Cooperative Oncology Group (ECOG) performance status score≤1; 5)the expected survival time was more than 3 months; 6)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;7)all patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment;8)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.

Exclusion Criteria:

1\) clinical diagnosis of bone marrow disease;2) imaging or pathological diagnosis of central nervous system or soft meningeal or bone or bone marrow metastases;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 radiochemotherapy contraindications;7)positive for human immunodeficiency virus (HIV);8)acute or chronic active hepatitis B or hepatitis C infection;9)History of gastrointestinal perforation and/or fistula, clinical signs or symptoms of intestinal obstruction and/or gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhoea), Crohn's disease, ulcerative colitis or chronic diarrhoea within the previous 6 months;10)evidence of an intra-abdominal pneumoperitoneum that cannot be explained by puncture or recent surgical intervention.

Outcome Measures

Primary Outcomes

Incidence of Grade 3-4 neutropenia

Incidence of Grade 3-4 neutropenia

Time frame: 6 months

Time to reconstruct haematopoietic function

Time to reconstruct haematopoietic function

Time frame: 6 months

Secondary Outcomes

the rate of postponement of the course of chemoradiotherapy

the rate of postponement of the course of chemoradiotherapy

Time frame: 3 months

reduction in chemotherapy dose

reduction in chemotherapy dose

Time frame: 3 months

Incidence of febrile neutropenia (FN)

Incidence of febrile neutropenia (FN)

Time frame: 3 months

Incidence of hematopoietic stem cell reinfusion treatment Adverse Events [Safety and Tolerability])

Incidence of hematopoietic stem cell reinfusion treatment Adverse Events \[Safety and Tolerability\])

Time frame: 1 months

Locations

Chongqing University Cancer Hospital, Chongqing, China

Linked Papers

2021-09-21

Correlations between bone marrow radiation dose and hematologic toxicity in locally advanced cervical cancer patients receiving chemoradiation with cisplatin: a systematic review

Patients with locally advanced cervical cancer (LACC) treated with chemoradiation often experience hematologic toxicity (HT), as chemoradiation can induce bone marrow (BM) suppression. Studies on the relationship between BM dosimetric parameters and clinically significant HT might provide relevant indices for developing BM sparing (BMS) radiotherapy techniques. This systematic review studied the relationship between BM dose and HT in patients with LACC treated with primary cisplatin-based chemoradiation. A systematic search was conducted in Embase, Medline, and Web of Science. Eligibility criteria were treatment of LACC-patients with cisplatin-based chemoradiation and report of HT or complete blood cell count (CBC). The search identified 1346 papers, which were screened on title and abstract before two reviewers independently evaluated the full-text. 17 articles were included and scored according to a selection of the TRIPOD criteria. The mean TRIPOD score was 12.1 out of 29. Fourteen studies defining BM as the whole pelvic bone contour (PB) detected significant associations with V10 (3/14), V20 (6/14), and V40 (4/11). Recommended cut-off values were V10 > 95-75%, V20 > 80-65%, and V40 > 37-28%. The studies using lower density marrow spaces (PBM) or active bone marrow (ABM) as a proxy for BM only found limited associations with HT. Our study was the first literature review providing an overview of articles evaluating the correlation between BM and HT for patients with LACC undergoing cisplatin-based chemoradiation. There is a scarcity of studies independently validating developed prediction models between BM dose and HT. Future studies may use PB contouring to develop normal tissue complication probability models.