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

August 23, 2023 updated by: Fuling Zhou, Zhongnan Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
168

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Blood routine in plasma at Week 4
Time Frame: Day 0，Week 1，Week2，Week 3，Week 4
Hemoglobin in g/L
Day 0，Week 1，Week2，Week 3，Week 4
Change from Blood routine in plasma at Week 4
Time Frame: Day 0，Week 1，Week2，Week 3，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
Time Frame: Day 0，Week 1，Week2，Week 3，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
Time Frame: Day 0，Week 1，Week2，Week 3，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
Time Frame: Day 0，Week 1，Week2，Week 3，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
Time Frame: Day 0，Week 1，Week2，Week 3，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
Time Frame: Day 0，Week 1，Week2，Week 3，Week 4
Serum erythropoietin in ng/ml
Day 0，Week 1，Week2，Week 3，Week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes from iron metabolism indicators in plasma at week 4
Time Frame: Day 0，Week 1，Week2，Week 3，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
Time Frame: Day 0，Week 1，Week2，Week 3，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
Time Frame: Day 0，Week 1，Week2，Week 3，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
Time Frame: Day 0，Week 1，Week2，Week 3，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
Time Frame: Day 0，Week 1，Week2，Week 3，Week 4
transferrin saturation in percentage
Day 0，Week 1，Week2，Week 3，Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhongnan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 7, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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