Nasopharyngeal Carcinoma, Iron-deficiency, Anemia
Conditions
Keywords
Nasopharyngeal Carcinoma, iron-deficiency anemia
Brief 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.
Detailed description
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.
Interventions
Patients receive Iron isomaltoside after IC and CCRT
DRUGPolysaccharide Iron Complex Pill
Patients receive Polysaccharide Iron Complex Pill after IC and CCRT
RADIATIONIntensity-modulated radiotherapy
All patients received intensity-modulated radiotherapy before enrolled.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Volunteer and sign the informed consent in person. * Aged 18-65 * Pathological diagnosis of non-keratinizing NPC (differentiated or undifferentiated, as WHO II, III type). * Clinical stage of III-IVA（8thAJCC/UICC staging system） * Complete induction chemotherapy and concurrent chemoradiotherapy. * With ECOG score 0-1. * Female subjects: surgical sterilization or postmenopausal patients, or agree to use a medical approved contraceptive measure such as Intrauterine device (IUD), contraceptives or condoms during the study period. * HGB \<130g/L(male)，HGB\<120g/L(female). * Serum ferritin≤800ug/L。 * Liver function: ALT, AST \< 2.5 times the upper limit of normal (ULN), total bilirubin \< 2.0 × ULN; * Renal function: serum creatinine \<1.5×ULN.
Exclusion criteria
* Recurrence or distant metastasis nasopharyngeal carcinoma. * Keratinizing squamous cell carcinoma (WHO type I). * Pregnant or breastfeeding women, who are in their childbearing years and have not used effective contraception. * Previous or concurrently with other malignancies, exclude cured skin basal cell carcinoma and cervical carcinoma in situ. * Patients with severely diminished functions of the heart, liver, lung, kidney and bone marrow; * Serious, unmanaged medical conditions and infections. * Those with other therapeutic contraindications. * Use of other investigational medications or clinical studies concurrently. * Refused or incapacity to sign the informed consent to participate in the study. * People having mental or personality disorders, disability, or limited civil capacity. * Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study. * HGB\>130g/L(male)，HGB \>120g/L(female). * Received transfusion therapy before. * Receipt of oral or IV iron supplements or ESAs up to 4 weeks before inclusion * Ferritin \> 800 ng/ml * Ongoing bleeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hematopoietic response rate | 1 month | Hematopoietic response rate at one month after IC+CCRT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute side effects | 1 month | The acute side effects of iron isomaltide |
| Quality of life scores | 1 month | The scores of each scale of quality of life questionaires for FACT-An |
| Hematopoietic response rate | 2 month | Hematopoietic response rate at two months after IC+CCRT. |
| The score of concise fatigue scale | 1,2,3 months | Calculated by Concise fatigue scale |
| The difference of serum iron | 1,2,3 months | The difference of HGB after patients receiving iron supplements |
| The difference of HGB | 1,2,3 months | The difference of HGB after patients receiving iron supplements |
Countries
China
Contacts
Primary ContactQiu Yan Chen, Dr
Backup ContactShan Shan Guo, Dr
Outcome results
None listed