Treatment of chemotherapy-related anemia in blood cancer patients using Shengxuening Tablet
A Multicenter Randomized Controlled Study of Shengxuening Tablet in the Treatment of Chemotherapy-related Anemia in Hematologic Tumors
This study is testing if the Shengxuening Tablet can help improve anemia in adults with blood cancer who are undergoing chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 168 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zhongnan Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05784870 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of Shengxuening Tablet in treating chemotherapy-related anemia (CRA) in patients with hematological malignancies. CRA is a common complication in cancer patients that significantly impacts their quality of life and treatment outcomes. The study aims to enroll patients aged over 18 with specific hemoglobin levels and a diagnosis of blood cancer complicated by anemia. Participants will receive the Shengxuening Tablet alongside ferrous succinate to assess improvements in hemoglobin levels and overall well-being.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with blood cancer and experiencing anemia with hemoglobin levels between 60g/L and 100g/L.
Not a fit: Patients with severe anemia (hemoglobin ≤ 60g/L), those requiring urgent blood transfusions, or individuals with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life and treatment outcomes for patients suffering from chemotherapy-related anemia.
How similar studies have performed: While there is limited information on the specific use of Shengxuening Tablet, other studies have shown promise in treating chemotherapy-related anemia with various interventions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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/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.
Where this trial is running
Wuhan, Hubei
- Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Zhou Fuling
- Email: zhoufuling@163.com.cn
- Phone: 18986265580
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.