A Study of Shengxuening Tablet in the Treatment of Chemotherapy-related Anemia in Hematologic Tumors

NCT05784870 | Unknown Phase 3

• 1 other identifier: 06
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematological Malignancy; Cancer-Related Anemia

Keywords

Shengxuening tablet; chemotherapy-related Anemia

Outcome Measures

Primary Outcomes (7)

• Change from Blood routine in plasma at Week 4

  Hemoglobin in g/L

  Day 0，Week 1，Week2，Week 3，Week 4

• Change from Blood routine in plasma at Week 4

  Red Blood Cell in 10\^12/L

  Day 0，Week 1，Week2，Week 3，Week 4

• Change from Blood routine in plasma at Week 4

  mean corpuscular hemoglobin in pg

  Day 0，Week 1，Week2，Week 3，Week 4

• Change from Blood routine in plasma at Week 4

  mean corpuscular volume in fL

  Day 0，Week 1，Week2，Week 3，Week 4

• Change from Blood routine in plasma at Week 4

  Red blood cell specific volume in percentage

  Day 0，Week 1，Week2，Week 3，Week 4

• Change from Blood routine in plasma at Week 4

  Reticulocyte in 10\^9/L

  Day 0，Week 1，Week2，Week 3，Week 4

• Change from Blood routine in plasma at Week 4

  Serum erythropoietin in ng/ml

  Day 0，Week 1，Week2，Week 3，Week 4

Secondary Outcomes (5)

• Changes from iron metabolism indicators in plasma at week 4

  Day 0，Week 1，Week2，Week 3，Week 4

• Changes from iron metabolism indicators in plasma at week 4

  Day 0，Week 1，Week2，Week 3，Week 4

• Changes from iron metabolism indicators in plasma at week 4

  Day 0，Week 1，Week2，Week 3，Week 4

• Changes from iron metabolism indicators in plasma at week 4

  Day 0，Week 1，Week2，Week 3，Week 4

• Changes from iron metabolism indicators in plasma at week 4

  Day 0，Week 1，Week2，Week 3，Week 4

Study Arms (2)

Shengxuening Tablets

EXPERIMENTAL

Oral treatment with Shengxuening Tablets 1 week before chemotherapy, usage: 0.5gtid, for 28 consecutive days

Drug: Shengxuening Tablet

ferrous succinate

ACTIVE COMPARATOR

Oral treatment with ferrous succinate 1 week before chemotherapy, usage: 200mgqd, for 28 consecutive days

Drug: Ferrous succinate

Interventions

Shengxuening Tablet DRUG

Oral treatment with Shengxuening Tablets 1 week before chemotherapy, usage: 0.5gtid, for 28 consecutive days

Shengxuening Tablets

Ferrous succinate DRUG

Oral treatment with ferrous succinate 1 week before chemotherapy, usage: 200mgqd, for 28 consecutive days

ferrous succinate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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/L\<Hb≤100g/L;
• Willingness to treat

You may not qualify if:

• During the screening period of ≤1 week, hemoglobin (Hb)≤60g/L
• History of blood transfusion within 1 month;
• Urgent blood transfusion or EPO infusion is required within the screening period of ≤1 week;
• Folic acid or vitamin B12 deficiency;
• History of iron allergy, history of allergy or intolerance to the study drug;
• Pregnant and lactating women;
• Age \<18 years old and body weight ≤35kg;
• Participated in other clinical drug research in the past 3 months;
• Severe cardiac insufficiency (NYHA grade III or above);
• Severe abnormal liver function (ALT, AST and TBIL ≥ 2 times the upper limit of normal value);
• Severe renal insufficiency (creatinine clearance ≤ 15ml/min);
• Severe mental disorder;
• Acute and chronic blood loss;
• Combined with a second tumor;
• Ferritin\>500μg/L;

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

shengxuening; ferrous succinate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Zhou Fuling

CONTACT

18986265580; zhoufuling@163.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head,Division of Hematology; Professor of Hematology; Doctoral advisor

Study Record Dates

• First Submitted: February 25, 2023
• First Posted: March 27, 2023
• Study Start: February 7, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 25, 2023

Record last verified: 2023-08

Locations

CN (1)