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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.
Iron-deficiency anemia patients with locally advanced nasopharyngeal carcinoma will be enrolled and receive iron Isomaltide or oral iron supplement after randomised. The hematopoietic response rate, tolerance, acute side effects, qualtiy of life and long time survival would be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron Isomaltide | Experimental | Patients receive iron Isomaltide after anti-tumor therapy. |
|
| Oral iron supplement | Active Comparator | Patients receive polysaccharide iron complex after anti-tumor therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron Isomaltoside 1000 | Drug | Patients receive Iron isomaltoside after IC and CCRT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hematopoietic response rate | Hematopoietic response rate at one month after IC+CCRT. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Hematopoietic response rate | Hematopoietic response rate at two months after IC+CCRT. | 2 month |
| Hematopoietic response rate | Hematopoietic response rate at three months after IC+CCRT. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiu Yan Chen, Dr | Contact | 020-87343380 | chenqy@sysucc.org.cn | |
| Shan Shan Guo, Dr | Contact | 020-87343380 | guoshsh@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shan Shan Guo, Dr | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| Polysaccharide Iron Complex Pill | Drug | Patients receive Polysaccharide Iron Complex Pill after IC and CCRT |
|
| Intensity-modulated radiotherapy | Radiation | All patients received intensity-modulated radiotherapy before enrolled. |
|
| 3 month |
| Acute side effects | The acute side effects of iron isomaltide | 1 month |
| Quality of life scores | The scores of each scale of quality of life questionaires for FACT-An | 1 month |
| The difference of HGB | The difference of HGB after patients receiving iron supplements | 1,2,3 months |
| The score of concise fatigue scale | Calculated by Concise fatigue scale | 1,2,3 months |
| The difference of serum iron | The difference of HGB after patients receiving iron supplements | 1,2,3 months |
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| D018798 | Anemia, Iron-Deficiency |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D000747 | Anemia, Hypochromic |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C557707 | iron isomaltoside 1000 |
| C078972 | Niferex |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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