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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hematological Malignancy; Cancer-Related Anemia
• Intervention / Treatment: Drug: Shengxuening Tablet; Drug: Ferrous succinate

• Study Type: Interventional
• Enrollment (Estimated): 168
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Zhou Fuling; Phone Number: 18986265580; Email: zhoufuling@163.com.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Recruiting
      • Zhongnan Hospital of Wuhan University
      • Contact: Zhou Fuling, director; Phone Number: +86-02767813137; Email: zhoufuling@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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/L<Hb≤100g/L;
• Willingness to treat

Exclusion Criteria:

• 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;
• Combined with active tuberculosis;
• Failure to cooperate with treatment according to doctor's advice.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shengxuening Tablets; Oral treatment with Shengxuening Tablets 1 week before chemotherapy, usage: 0.5gtid, for 28 consecutive days	Drug: Shengxuening Tablet; Oral treatment with Shengxuening Tablets 1 week before chemotherapy, usage: 0.5gtid, for 28 consecutive days
Active Comparator: ferrous succinate; Oral treatment with ferrous succinate 1 week before chemotherapy, usage: 200mgqd, for 28 consecutive days	Drug: Ferrous succinate; Oral treatment with ferrous succinate 1 week before chemotherapy, usage: 200mgqd, for 28 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from iron metabolism indicators in plasma at week 4	serum ferritin in μg/L	Day 0，Week 1，Week2，Week 3，Week 4
Changes from iron metabolism indicators in plasma at week 4	serum iron in μmol/L	Day 0，Week 1，Week2，Week 3，Week 4
Changes from iron metabolism indicators in plasma at week 4	total iron binding capacity in μmol/L	Day 0，Week 1，Week2，Week 3，Week 4
Changes from iron metabolism indicators in plasma at week 4	unsaturated iron binding capacity in μmol/L	Day 0，Week 1，Week2，Week 3，Week 4
Changes from iron metabolism indicators in plasma at week 4	transferrin saturation in percentage	Day 0，Week 1，Week2，Week 3，Week 4

Collaborators and Investigators

• Sponsor: Zhongnan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 25, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Shengxuening tablet; chemotherapy-related Anemia
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms; Anemia; Hematinics; Ferrous succinate
• Other Study ID Numbers: 06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No