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

Phase 2

Recruiting

• Conditions: Nasopharyngeal Carcinoma; Anemia; Iron-deficiency
• Interventions: Drug: Polysaccharide Iron Complex Pill; Drug: Iron Isomaltoside 1000; Radiation: Intensity-modulated radiotherapy

• Registration Number: NCT05913414
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study First Submitted: 2023-04-23
• Study Start: 2023-05-05
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-19
• Last Update Submitted: 2023-06-19
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-22
• Primary Completion: 2024-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral iron supplement	Intensity-modulated radiotherapy	Patients receive polysaccharide iron complex after anti-tumor therapy.
Oral iron supplement	Polysaccharide Iron Complex Pill	Patients receive polysaccharide iron complex after anti-tumor therapy.
Iron Isomaltide	Intensity-modulated radiotherapy	Patients receive iron Isomaltide after anti-tumor therapy.
Iron Isomaltide	Iron Isomaltoside 1000	Patients receive iron Isomaltide after anti-tumor therapy.

Primary Outcome Measures

Name	Time	Method
Hematopoietic response rate	1 month	Hematopoietic response rate at one month after IC+CCRT.

Secondary Outcome Measures

Name	Time	Method
The difference of HGB	1,2,3 months	The difference of HGB after patients receiving iron supplements
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
The score of concise fatigue scale	1,2,3 months	Calculated by Concise fatigue scale
Hematopoietic response rate	3 month	Hematopoietic response rate at three months after IC+CCRT.
The difference of serum iron	1,2,3 months	The difference of HGB after patients receiving iron supplements

Trial Locations

Locations (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China