A Randomised Phase II Trial of Iron Isomaltide Versus Oral Iron Supplement for Radiotherapy or Chemotherapy Associated Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma
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.
• 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.