A Phase 3 interventional study of Shengxuening Tablet and Ferrous succinate in Hematological Malignancy and Cancer-Related Anemia, sponsored by Zhongnan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-25.
Sponsored by Zhongnan Hospital · Phase 3, Interventional, and Treatment
Cancer-related anemia (CRA) is one of the common accompanying diseases of malignant tumors. In 2019, a cross-sectional survey on the anemia status of 7324 malignant tumor patients in 97 hospitals in China found that the incidence of CRA was about 49.24%. 92.84% of the patients have not been given enough attention and effective treatment. According to the European Oncological Anemia Survey, CRA has the highest incidence in leukemia patients, followed by lymphoma/myeloma. CRA not only leads to a decline in the quality of life of patients, but also reduces the sensitivity to radiotherapy and chemotherapy, and also causes hypoxia in tumor tissue, which affects the prognosis of patients as an independent factor. At present, the treatment of CRA mainly includes blood transfusion therapy, erythropoiesis-stimulating agent (ESA) therapy, iron supplementation, etc. Conventional oral iron has low bioavailability and strong gastrointestinal irritation. Although intravenous iron can quickly replenish iron, excessive iron supplementation is prone to iron overload. Less acceptable. Shengxuening Tablets are derived from silkworm excrement. The main components of iron chlorophyllin and chlorophyll derivatives are very similar in structure to heme, and can be directly absorbed by small intestinal mucosal cells, effectively supplementing the iron elements required in the process of hematopoiesis. The investigators found that Shengxuening Tablets can increase the number of peripheral blood cells in mouse models of myelosuppression, improve bone marrow morphology, reverse the decrease in body weight and spleen index, and increase the levels of serum erythropoietin and granulocyte-macrophage colony-stimulating factor . Real-time fluorescent quantitative PCR and Western blot analysis showed increased expression levels of stem cell factor (SCF), JAK2 and STAT3 in the liver. These results indicated that Shengxuening Tablets promoted the recovery of hematopoietic function in myelosuppressive models by increasing the secretion of hematopoietic factors and activating the JAK2/STAT3 pathway. Therefore, in order to further confirm the preventive effect, effectiveness and safety of Shengxuening Tablets in the treatment of anemia in patients with hematological tumors complicated with anemia, this clinical trial was designed.
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This study's planned enrollment of 168 is above the median of 45 across 1,090 interventional studies indexed under Hematologic Neoplasms.
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Exclusion Criteria:
Oral treatment with Shengxuening Tablets 1 week before chemotherapy, usage: 0.5gtid, for 28 consecutive days
Drug: Shengxuening Tablet
Oral treatment with ferrous succinate 1 week before chemotherapy, usage: 200mgqd, for 28 consecutive days
Drug: Ferrous succinate
Oral treatment with Shengxuening Tablets 1 week before chemotherapy, usage: 0.5gtid, for 28 consecutive days
Oral treatment with ferrous succinate 1 week before chemotherapy, usage: 200mgqd, for 28 consecutive days
Change from Blood routine in plasma at Week 4
Hemoglobin in g/L
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Change from Blood routine in plasma at Week 4
Red Blood Cell in 10\^12/L
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Change from Blood routine in plasma at Week 4
mean corpuscular hemoglobin in pg
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Change from Blood routine in plasma at Week 4
mean corpuscular volume in fL
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Change from Blood routine in plasma at Week 4
Red blood cell specific volume in percentage
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Change from Blood routine in plasma at Week 4
Reticulocyte in 10\^9/L
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Change from Blood routine in plasma at Week 4
Serum erythropoietin in ng/ml
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Changes from iron metabolism indicators in plasma at week 4
serum ferritin in μg/L
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Changes from iron metabolism indicators in plasma at week 4
serum iron in μmol/L
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Changes from iron metabolism indicators in plasma at week 4
total iron binding capacity in μmol/L
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Changes from iron metabolism indicators in plasma at week 4
unsaturated iron binding capacity in μmol/L
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Changes from iron metabolism indicators in plasma at week 4
transferrin saturation in percentage
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Plan to share: Undecided
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