Iron Isomaltide for Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma
NCT05913414 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2023-06-22
Summary
Primary purpose: To evaluate the difference of hematopoietic response rate at 1 month after concurrent chemoradiotherapy between iron isomaltide and oral iron supplement for treating iron-deficiency anemia patients with locally advanced nasopharyngeal carcinoma.
Secondary purpose:
To evaluate the difference of hematopoietic response rate, tolerance, acute side effects, qualtiy of life at 2 months and 3 months after concurrent chemoradiotherapy between Iron Isomaltide and oral iron supplement for treating iron-deficiency anemia patients with locally advanced nasopharyngeal carcinoma.
Conditions
- Nasopharyngeal Carcinoma
- Iron-deficiency
- Anemia
Interventions
- DRUG
-
Iron Isomaltoside 1000
Patients receive Iron isomaltoside after IC and CCRT
- DRUG
-
Polysaccharide Iron Complex Pill
Patients receive Polysaccharide Iron Complex Pill after IC and CCRT
- RADIATION
-
Intensity-modulated radiotherapy
All patients received intensity-modulated radiotherapy before enrolled.
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Principal Investigators
-
Shan Shan Guo, Dr · Sun Yat-sen University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-05
- Primary Completion
- 2024-05-30
- Completion
- 2026-05-30
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- China
Study Locations
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