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Trial Title:
A Study of Shengxuening Tablet in the Treatment of Chemotherapy-related Anemia in Hematologic Tumors
NCT ID:
NCT05784870
Condition:
Hematological Malignancy
Cancer-Related Anemia
Conditions: Official terms:
Hematologic Neoplasms
Anemia
Ferrous succinate
Conditions: Keywords:
Shengxuening tablet
chemotherapy-related Anemia
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Shengxuening Tablet
Description:
Oral treatment with Shengxuening Tablets 1 week before chemotherapy, usage: 0.5gtid, for
28 consecutive days
Arm group label:
Shengxuening Tablets
Intervention type:
Drug
Intervention name:
Ferrous succinate
Description:
Oral treatment with ferrous succinate 1 week before chemotherapy, usage: 200mgqd, for 28
consecutive days
Arm group label:
ferrous succinate
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age>18 years old, gender is not limited;
- Patients diagnosed with blood cancer complicated with anemia;
- During the screening period of ≤1 week, hemoglobin (Hb): 60g/L500μg/L;
- Combined with active tuberculosis;
- Failure to cooperate with treatment according to doctor's advice.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongnan Hospital of Wuhan University
Address:
City:
Wuhan
Zip:
430071
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhou Fuling, director
Phone:
+86-02767813137
Email:
zhoufuling@163.com
Start date:
February 7, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Zhongnan Hospital
Agency class:
Other
Source:
Zhongnan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05784870
