NCT05913414

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nasopharyngeal Carcinoma
• Iron-deficiency
• Anemia

Interventions

Type	Name	Description
DRUG	Iron Isomaltoside 1000	Patients receive Iron isomaltoside after IC and CCRT
DRUG	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.

Timeline

• Start date: 2023-05-05
• Primary completion: 2024-05-30
• Completion: 2026-05-30
• First posted: 2023-06-22
• Last updated: 2023-06-22

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study
• FDA-regulated device study