Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Iron-deficiency | — | UNRESOLVED | — |
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensity-modulated radiotherapy | Radiation | — | UNRESOLVED |
| Iron Isomaltoside 1000 | Drug | — | UNRESOLVED |
| Polysaccharide Iron Complex Pill | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Iron Isomaltide
- description
- Patients receive iron Isomaltide after anti-tumor therapy.
- interventionNames
- Drug: Iron Isomaltoside 1000
- Radiation: Intensity-modulated radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Oral iron supplement
- description
- Patients receive polysaccharide iron complex after anti-tumor therapy.
- interventionNames
- Drug: Polysaccharide Iron Complex Pill
- Radiation: Intensity-modulated radiotherapy
Primary outcomes (1)
- measure
- Hematopoietic response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
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