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

Primary Purpose

Nasopharyngeal Carcinoma, Iron-deficiency, Anemia

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Iron Isomaltoside 1000
Polysaccharide Iron Complex Pill
Intensity-modulated radiotherapy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, iron-deficiency anemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Iron Isomaltide

Oral iron supplement

Arm Description

Patients receive iron Isomaltide after anti-tumor therapy.

Patients receive polysaccharide iron complex after anti-tumor therapy.

Outcomes

Primary Outcome Measures

Hematopoietic response rate
Hematopoietic response rate at one month after IC+CCRT.

Secondary Outcome Measures

Hematopoietic response rate
Hematopoietic response rate at two months after IC+CCRT.
Hematopoietic response rate
Hematopoietic response rate at three months after IC+CCRT.
Acute side effects
The acute side effects of iron isomaltide
Quality of life scores
The scores of each scale of quality of life questionaires for FACT-An
The difference of HGB
The difference of HGB after patients receiving iron supplements
The score of concise fatigue scale
Calculated by Concise fatigue scale
The difference of serum iron
The difference of HGB after patients receiving iron supplements

Full Information

First Posted
April 23, 2023
Last Updated
June 19, 2023
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05913414
Brief Title
Iron Isomaltide for Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2023 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
May 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma, Iron-deficiency, Anemia
Keywords
Nasopharyngeal Carcinoma, iron-deficiency anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Iron Isomaltide
Arm Type
Experimental
Arm Description
Patients receive iron Isomaltide after anti-tumor therapy.
Arm Title
Oral iron supplement
Arm Type
Active Comparator
Arm Description
Patients receive polysaccharide iron complex after anti-tumor therapy.
Intervention Type
Drug
Intervention Name(s)
Iron Isomaltoside 1000
Other Intervention Name(s)
Iron isomaltoside
Intervention Description
Patients receive Iron isomaltoside after IC and CCRT
Intervention Type
Drug
Intervention Name(s)
Polysaccharide Iron Complex Pill
Intervention Description
Patients receive Polysaccharide Iron Complex Pill after IC and CCRT
Intervention Type
Radiation
Intervention Name(s)
Intensity-modulated radiotherapy
Intervention Description
All patients received intensity-modulated radiotherapy before enrolled.
Primary Outcome Measure Information:
Title
Hematopoietic response rate
Description
Hematopoietic response rate at one month after IC+CCRT.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Hematopoietic response rate
Description
Hematopoietic response rate at two months after IC+CCRT.
Time Frame
2 month
Title
Hematopoietic response rate
Description
Hematopoietic response rate at three months after IC+CCRT.
Time Frame
3 month
Title
Acute side effects
Description
The acute side effects of iron isomaltide
Time Frame
1 month
Title
Quality of life scores
Description
The scores of each scale of quality of life questionaires for FACT-An
Time Frame
1 month
Title
The difference of HGB
Description
The difference of HGB after patients receiving iron supplements
Time Frame
1,2,3 months
Title
The score of concise fatigue scale
Description
Calculated by Concise fatigue scale
Time Frame
1,2,3 months
Title
The difference of serum iron
Description
The difference of HGB after patients receiving iron supplements
Time Frame
1,2,3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiu Yan Chen, Dr
Phone
020-87343380
Email
chenqy@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Shan Shan Guo, Dr
Phone
020-87343380
Email
guoshsh@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shan Shan Guo, Dr
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiqiang Mai, MD,Ph.D
Phone
86-20-8734-3643
Email
maihq@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Qiuyan Chen, MD,Ph.D
Phone
86-20-8734-3380
Email
chenqy@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Haiqiang Mai, MD,Ph.D
First Name & Middle Initial & Last Name & Degree
Qiuyan Chen, MD,Ph.D
First Name & Middle Initial & Last Name & Degree
Shanshan Guo, MD,Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No

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

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