RecruitingPhase 2NCT05913414

Iron Isomaltide for Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma

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

Sponsor

Sun Yat-sen University

Enrollment

120 participants

Start Date

May 5, 2023

Study Type

INTERVENTIONAL

Conditions

Nasopharyngeal Carcinoma Anemia Iron-deficiency

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria11

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 Criteria16

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.