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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05913414

Collaborator

(none)

120

Enrollment

Location

Arms

36.8

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma Iron-deficiency Anemia	Drug: Iron Isomaltoside 1000 Drug: Polysaccharide Iron Complex Pill Radiation: Intensity-modulated radiotherapy	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 5, 2023

Anticipated Primary Completion Date :

May 30, 2024

Anticipated Study Completion Date :

May 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Iron Isomaltide Patients receive iron Isomaltide after anti-tumor therapy.	Drug: Iron Isomaltoside 1000 Patients receive Iron isomaltoside after IC and CCRT Other Names: Iron isomaltoside Radiation: Intensity-modulated radiotherapy All patients received intensity-modulated radiotherapy before enrolled.
Active Comparator: Oral iron supplement Patients receive polysaccharide iron complex after anti-tumor therapy.	Drug: Polysaccharide Iron Complex Pill Patients receive Polysaccharide Iron Complex Pill after IC and CCRT Radiation: Intensity-modulated radiotherapy All patients received intensity-modulated radiotherapy before enrolled.

Arm

Intervention/Treatment

Experimental: Iron Isomaltide

Patients receive iron Isomaltide after anti-tumor therapy.

Drug: Iron Isomaltoside 1000

Patients receive Iron isomaltoside after IC and CCRT

Other Names:

Iron isomaltoside

Radiation: Intensity-modulated radiotherapy

All patients received intensity-modulated radiotherapy before enrolled.

Active Comparator: Oral iron supplement

Patients receive polysaccharide iron complex after anti-tumor therapy.

Drug: Polysaccharide Iron Complex Pill

Patients receive Polysaccharide Iron Complex Pill after IC and CCRT

Radiation: Intensity-modulated radiotherapy

All patients received intensity-modulated radiotherapy before enrolled.

Outcome Measures

Primary Outcome Measures

Hematopoietic response rate [1 month]
Hematopoietic response rate at one month after IC+CCRT.

Secondary Outcome Measures

Hematopoietic response rate [2 month]
Hematopoietic response rate at two months after IC+CCRT.
Hematopoietic response rate [3 month]
Hematopoietic response rate at three months after IC+CCRT.
Acute side effects [1 month]
The acute side effects of iron isomaltide
Quality of life scores [1 month]
The scores of each scale of quality of life questionaires for FACT-An
The difference of HGB [1,2,3 months]
The difference of HGB after patients receiving iron supplements
The score of concise fatigue scale [1,2,3 months]
Calculated by Concise fatigue scale
The difference of serum iron [1,2,3 months]
The difference of HGB after patients receiving iron supplements

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.