Iron Isomaltide for Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma

NCT05913414 | Recruiting Phase 2 FDA Drug FDA Device

• 1 other identifier: 2022-747-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Carcinoma; Iron-deficiency; Anemia

Keywords

Nasopharyngeal Carcinoma; iron-deficiency anemia

Outcome Measures

Primary Outcomes (1)

• Hematopoietic response rate

  Hematopoietic response rate at one month after IC+CCRT.

  1 month

Secondary Outcomes (7)

• Hematopoietic response rate

  2 month

• Hematopoietic response rate

  3 month

• Acute side effects

  1 month

• Quality of life scores

  1 month

• The difference of HGB

  1,2,3 months

Study Arms (2)

Iron Isomaltide

EXPERIMENTAL

Patients receive iron Isomaltide after anti-tumor therapy.

Drug: Iron Isomaltoside 1000; Radiation: Intensity-modulated radiotherapy

Oral iron supplement

ACTIVE COMPARATOR

Patients receive polysaccharide iron complex after anti-tumor therapy.

Drug: Polysaccharide Iron Complex Pill; Radiation: Intensity-modulated radiotherapy

Interventions

Iron Isomaltoside 1000 DRUG

Patients receive Iron isomaltoside after IC and CCRT

Also known as: Iron isomaltoside

Iron Isomaltide

Polysaccharide Iron Complex Pill DRUG

Patients receive Polysaccharide Iron Complex Pill after IC and CCRT

Oral iron supplement

Intensity-modulated radiotherapy RADIATION

All patients received intensity-modulated radiotherapy before enrolled.

Iron Isomaltide; Oral iron supplement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Ferritin \> 800 ng/ml
• Ongoing bleeding.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Anemia, Iron-Deficiency; Anemia

Interventions

iron isomaltoside 1000; Niferex; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Shan Shan Guo, Dr

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiu Yan Chen, Dr

CONTACT

020-87343380; chenqy@sysucc.org.cn

Shan Shan Guo, Dr

CONTACT

020-87343380; guoshsh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 23, 2023
• First Posted: June 22, 2023
• Study Start: May 5, 2023
• Primary Completion: May 30, 2024
• Study Completion (Estimated): May 30, 2026
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)