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

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

Plain Language Summary

Simplified for easier understanding

This study is testing intravenous iron (iron isomaltide) to treat iron-deficiency anemia in people with locally advanced nasopharyngeal cancer (a cancer at the back of the nose/throat) who are undergoing intensive chemotherapy and radiation. **You may be eligible if...** - You are 18–65 years old - You have stage III–IVA nasopharyngeal cancer - You completed induction chemotherapy and are now receiving concurrent chemoradiotherapy - You have iron-deficiency anemia **You may NOT be eligible if...** - You have a known allergy to iron products - You have iron overload or hemochromatosis - You have active serious infection or uncontrolled bleeding - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIron Isomaltoside 1000

Patients receive Iron isomaltoside after IC and CCRT

DRUGPolysaccharide Iron Complex Pill

Patients receive Polysaccharide Iron Complex Pill after IC and CCRT

RADIATIONIntensity-modulated radiotherapy

All patients received intensity-modulated radiotherapy before enrolled.


Locations(1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT05913414


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