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Trial Title:
Iron Isomaltide for Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma
NCT ID:
NCT05913414
Condition:
Nasopharyngeal Carcinoma
Iron-deficiency
Anemia
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Anemia
Anemia, Iron-Deficiency
Iron Deficiencies
Iron
Iron isomaltoside 1000
Ferric Compounds
Conditions: Keywords:
Nasopharyngeal Carcinoma
iron-deficiency anemia
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Iron Isomaltoside 1000
Description:
Patients receive Iron isomaltoside after IC and CCRT
Arm group label:
Iron Isomaltide
Other name:
Iron isomaltoside
Intervention type:
Drug
Intervention name:
Polysaccharide Iron Complex Pill
Description:
Patients receive Polysaccharide Iron Complex Pill after IC and CCRT
Arm group label:
Oral iron supplement
Intervention type:
Radiation
Intervention name:
Intensity-modulated radiotherapy
Description:
All patients received intensity-modulated radiotherapy before enrolled.
Arm group label:
Iron Isomaltide
Arm group label:
Oral iron supplement
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Haiqiang Mai, MD,Ph.D
Phone:
86-20-8734-3643
Email:
maihq@mail.sysu.edu.cn
Contact backup:
Last name:
Qiuyan Chen, MD,Ph.D
Phone:
86-20-8734-3380
Email:
chenqy@mail.sysu.edu.cn
Investigator:
Last name:
Haiqiang Mai, MD,Ph.D
Email:
Principal Investigator
Investigator:
Last name:
Qiuyan Chen, MD,Ph.D
Email:
Principal Investigator
Investigator:
Last name:
Shanshan Guo, MD,Ph.D
Email:
Sub-Investigator
Start date:
May 5, 2023
Completion date:
May 30, 2026
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05913414
