Actively Recruiting
Iron Isomaltide for Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma
Led by Sun Yat-sen University · Updated on 2023-06-22
120
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Iron Isomaltide for Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer and sign the informed consent in person.
- Aged 18-65.
- Pathological diagnosis of non-keratinizing nasopharyngeal carcinoma (WHO II, III type).
- Clinical stage III-IVA (8th AJCC/UICC staging system).
- Completed induction chemotherapy and concurrent chemoradiotherapy.
- ECOG score 0-1.
- Female subjects must be surgically sterilized, postmenopausal, or agree to use approved contraception during the study.
- Hemoglobin (HGB) less than 130 g/L for males, less than 120 g/L for females.
- Serum ferritin less than or equal to 800 ug/L.
- Liver function tests: ALT and AST less than 2.5 times the upper limit of normal, total bilirubin less than 2.0 times the upper limit.
- Renal function: serum creatinine less than 1.5 times the upper limit of normal.
You will not qualify if you...
- Recurrence or distant metastasis of nasopharyngeal carcinoma.
- Keratinizing squamous cell carcinoma (WHO type I).
- Pregnant or breastfeeding women, or women of childbearing age not using effective contraception.
- Previous or concurrent other malignancies, except cured skin basal cell carcinoma and cervical carcinoma in situ.
- Severe dysfunction of heart, liver, lung, kidney, or bone marrow.
- Serious unmanaged medical conditions or infections.
- Other therapeutic contraindications.
- Use of other investigational medications or participation in other clinical studies concurrently.
- Refusal or incapacity to sign informed consent.
- Mental or personality disorders, disability, or limited civil capacity.
- Other significant medical illnesses increasing study risk.
- Hemoglobin above 130 g/L for males or above 120 g/L for females.
- Prior transfusion therapy.
- Use of oral or IV iron supplements or erythropoiesis-stimulating agents within 4 weeks before inclusion.
- Serum ferritin above 800 ng/ml.
- Ongoing bleeding.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Q
Qiu Yan Chen, Dr
CONTACT
S
Shan Shan Guo, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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