Hematological MalignancyPhase 3NCT05784870
A Study of Shengxuening Tablet in the Treatment of Chemotherapy-related Anemia in Hematologic Tumors
A Phase 3 study testing Shengxuening Tablet and Ferrous succinate in people with Hematological Malignancy and Cancer-Related Anemia, run by Zhongnan Hospital at 1 site in China.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Malignancy, Cancer-Related Anemia
- What is being tested?
- Shengxuening Tablet and Ferrous succinate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2023to 31 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Zhou Fuling, director, +86-02767813137, zhoufuling@163.com
About this study
Official title: 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.
- Conditions
- Hematological Malignancy, Cancer-Related Anemia
- Being tested
- Shengxuening Tablet, Ferrous succinate
- Keywords
- Shengxuening tablet, chemotherapy-related Anemia
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shengxuening TabletDrug
Oral treatment with Shengxuening Tablets 1 week before chemotherapy, usage: 0.5gtid, for 28 consecutive days
Ferrous succinateDrug
Oral treatment with ferrous succinate 1 week before chemotherapy, usage: 200mgqd, for 28 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Shengxuening Tablets | Experimental | Oral treatment with Shengxuening Tablets 1 week before chemotherapy, usage: 0.5gtid, for 28 consecutive days Receives: Drug: Shengxuening Tablet |
| ferrous succinate | Active comparator | Oral treatment with ferrous succinate 1 week before chemotherapy, usage: 200mgqd, for 28 consecutive days Receives: Drug: Ferrous succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Blood routine in plasma at Week 4
Hemoglobin in g/L
Measured: 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
Measured: Day 0，Week 1，Week2，Week 3，Week 4
Change from Blood routine in plasma at Week 4
mean corpuscular hemoglobin in pg
Measured: Day 0，Week 1，Week2，Week 3，Week 4
Change from Blood routine in plasma at Week 4
mean corpuscular volume in fL
Measured: 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
Measured: Day 0，Week 1，Week2，Week 3，Week 4
Change from Blood routine in plasma at Week 4
Reticulocyte in 10^9/L
Measured: Day 0，Week 1，Week2，Week 3，Week 4
Change from Blood routine in plasma at Week 4
Serum erythropoietin in ng/ml
Measured: Day 0，Week 1，Week2，Week 3，Week 4
Secondary outcomes (5)
Changes from iron metabolism indicators in plasma at week 4
serum ferritin in μg/L
Measured: Day 0，Week 1，Week2，Week 3，Week 4
Changes from iron metabolism indicators in plasma at week 4
serum iron in μmol/L
Measured: 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
Measured: 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
Measured: Day 0，Week 1，Week2，Week 3，Week 4
Changes from iron metabolism indicators in plasma at week 4
transferrin saturation in percentage
Measured: Day 0，Week 1，Week2，Week 3，Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start7 Feb 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuling Zhou, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784870
- Sponsor's protocol ID
- 06
- Status last verified
- Aug 2023
- First submitted
- 25 Feb 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Study of Shengxuening Tablet in the Treatment of Chemotherapy-related Anemia in Hematologic Tumors
- ClinicalTrials.gov ID
- NCT05784870
- Acronym / sponsor ID
- 06
- Conditions
- Hematological Malignancy, Cancer-Related Anemia
- Keywords
- Shengxuening tablet, chemotherapy-related Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shengxuening Tablets | Experimental | Drug: Shengxuening TabletOral treatment with Shengxuening Tablets 1 week before chemotherapy, usage: 0.5gtid, for 28 consecutive days |
| ferrous succinate | Active comparator | Drug: Ferrous succinateOral treatment with ferrous succinate 1 week before chemotherapy, usage: 200mgqd, for 28 consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shengxuening TabletOral treatment with Shengxuening Tablets 1 week before chemotherapy, usage: 0.5gtid, for 28 consecutive days | Drug | Shengxuening Tablets |
| Ferrous succinateOral treatment with ferrous succinate 1 week before chemotherapy, usage: 200mgqd, for 28 consecutive days | Drug | ferrous succinate |
Primary outcome
Change from Blood routine in plasma at Week 4
Time frame: Day 0，Week 1，Week2，Week 3，Week 4
Hemoglobin in g/L
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
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
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
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
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
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
5 secondary outcomes
Changes from iron metabolism indicators in plasma at week 4
Time frame: 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
Changes from iron metabolism indicators in plasma at week 4
Time frame: 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
Changes from iron metabolism indicators in plasma at week 4
Time frame: Day 0，Week 1，Week2，Week 3，Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Shengxuening Tablet and Ferrous succinate in people with Hematological Malignancy and Cancer-Related Anemia, run by Zhongnan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhou Fuling (18986265580, zhoufuling@163.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Blood routine in plasma at Week 4 (time frame: Day 0，Week 1，Week2，Week 3，Week 4). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.