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

Sun Yat-sen University

Status and phase: Enrolling; Phase 2

Conditions: Anemia; Iron-deficiency; Nasopharyngeal Carcinoma

Treatments: Drug: Polysaccharide Iron Complex Pill; Radiation: Intensity-modulated radiotherapy; Drug: Iron Isomaltoside 1000

Study type: Interventional

Funder types: Other

Identifiers

NCT05913414

2022-747-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Iron Isomaltide

Experimental group

Description:

Patients receive iron Isomaltide after anti-tumor therapy.

Treatment:

Drug: Iron Isomaltoside 1000

Radiation: Intensity-modulated radiotherapy

Oral iron supplement

Active Comparator group

Description:

Patients receive polysaccharide iron complex after anti-tumor therapy.

Treatment:

Drug: Polysaccharide Iron Complex Pill

Radiation: Intensity-modulated radiotherapy