Iron Isomaltide for Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma (NCT05913414) | Clinical Trial Compass
RecruitingPhase 2
Iron Isomaltide for Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma
China120 participantsStarted 2023-05-05
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 th…