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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05913414
• Other study ID #: 2022-747-01
• Status: Recruiting
• Phase: Phase 2
• Start date: May 5, 2023
• Est. completion date: May 30, 2026

Study information

• Verified date: June 2023
• Source: Sun Yat-sen University
• Contact: Qiu Yan Chen, Dr
• Phone: 020-87343380
• Email: chenqy[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Carcinoma
• Iron-deficiency
• Nasopharyngeal Carcinoma

Intervention

Drug:
• Iron Isomaltoside 1000
Patients receive Iron isomaltoside after IC and CCRT
• Polysaccharide Iron Complex Pill
Patients receive Polysaccharide Iron Complex Pill after IC and CCRT

Radiation:
• Intensity-modulated radiotherapy
All patients received intensity-modulated radiotherapy before enrolled.

Locations

Country	Name	City	State
China	Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematopoietic response rate	Hematopoietic response rate at one month after IC+CCRT.	1 month
Secondary	Hematopoietic response rate	Hematopoietic response rate at two months after IC+CCRT.	2 month
Secondary	Hematopoietic response rate	Hematopoietic response rate at three months after IC+CCRT.	3 month
Secondary	Acute side effects	The acute side effects of iron isomaltide	1 month
Secondary	Quality of life scores	The scores of each scale of quality of life questionaires for FACT-An	1 month
Secondary	The difference of HGB	The difference of HGB after patients receiving iron supplements	1,2,3 months
Secondary	The score of concise fatigue scale	Calculated by Concise fatigue scale	1,2,3 months
Secondary	The difference of serum iron	The difference of HGB after patients receiving iron supplements	1,2,3 months