Clinical trial NCT05913414: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Iron-deficiency
Anemia
Keywords: Nasopharyngeal Carcinoma
iron-deficiency anemia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Hematopoietic response rate
timeFrame: 1 month
Secondary outcomes:
measure: Hematopoietic response rate
timeFrame: 2 month
measure: Hematopoietic response rate
timeFrame: 3 month
measure: Acute side effects
timeFrame: 1 month
measure: Quality of life scores
timeFrame: 1 month
measure: The difference of HGB
timeFrame: 1,2,3 months
measure: The score of concise fatigue scale
timeFrame: 1,2,3 months
measure: The difference of serum iron
timeFrame: 1,2,3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Shan Shan Guo, Dr
role: PRINCIPAL_INVESTIGATOR
References: