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

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.

Study Overview

• Status: Recruiting
• Conditions: Nasopharyngeal Carcinoma; Iron-deficiency; Anemia
• Intervention / Treatment: Drug: Iron Isomaltoside 1000; Radiation: Intensity-modulated radiotherapy; Drug: Polysaccharide Iron Complex Pill

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qiu Yan Chen, Dr; Phone Number: 020-87343380; Email: chenqy@sysucc.org.cn
• Study Contact Backup: Name: Shan Shan Guo, Dr; Phone Number: 020-87343380; Email: guoshsh@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
      • Contact: Haiqiang Mai, MD,Ph.D; Phone Number: 86-20-8734-3643; Email: maihq@mail.sysu.edu.cn
      • Contact: Qiuyan Chen, MD,Ph.D; Phone Number: 86-20-8734-3380; Email: chenqy@mail.sysu.edu.cn
      • Principal Investigator: Haiqiang Mai, MD,Ph.D
      • Principal Investigator: Qiuyan Chen, MD,Ph.D
      • Sub-Investigator: Shanshan Guo, MD,Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iron Isomaltide; Patients receive iron Isomaltide after anti-tumor therapy.	Drug: Iron Isomaltoside 1000; Patients receive Iron isomaltoside after IC and CCRT; Other Names: Iron isomaltoside; Radiation: Intensity-modulated radiotherapy; All patients received intensity-modulated radiotherapy before enrolled.
Active Comparator: Oral iron supplement; Patients receive polysaccharide iron complex after anti-tumor therapy.	Radiation: Intensity-modulated radiotherapy; All patients received intensity-modulated radiotherapy before enrolled.; Drug: Polysaccharide Iron Complex Pill; Patients receive Polysaccharide Iron Complex Pill after IC and CCRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hematopoietic response rate	Hematopoietic response rate at one month after IC+CCRT.	1 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Shan Shan Guo, Dr, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2023
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: April 23, 2023
• First Submitted That Met QC Criteria: June 19, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Nasopharyngeal Carcinoma; iron-deficiency anemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Hematologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma; Anemia, Iron-Deficiency; Anemia; Iron Deficiencies; Physiological Effects of Drugs; Trace Elements; Micronutrients; Hematinics; Iron isomaltoside 1000; Iron; Ferric Compounds
• Other Study ID Numbers: 2022-747-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes