Iron treatment for anemia in patients with advanced nasopharyngeal cancer
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
This study is testing whether a new iron treatment can help people with advanced nasopharyngeal cancer and anemia feel better after their chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05913414 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of iron isomaltide compared to oral iron supplements in improving hematopoietic response rates in patients with iron-deficiency anemia who have locally advanced nasopharyngeal carcinoma. Participants will be randomly assigned to receive either treatment after completing induction chemotherapy and concurrent chemoradiotherapy. The study will assess various outcomes, including tolerance, acute side effects, quality of life, and long-term survival over a period of three months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a pathological diagnosis of non-keratinizing nasopharyngeal carcinoma and iron-deficiency anemia.
Not a fit: Patients with recurrence or distant metastasis of nasopharyngeal carcinoma or those with keratinizing squamous cell carcinoma will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of iron-deficiency anemia in patients undergoing treatment for nasopharyngeal carcinoma.
How similar studies have performed: While there have been studies on iron supplementation in cancer patients, the specific use of iron isomaltide in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Shan Shan Guo, Dr — Sun Yat-sen University
- Study coordinator: Qiu Yan Chen, Dr
- Email: chenqy@sysucc.org.cn
- Phone: 020-87343380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.