Nasopharyngeal CarcinomaPhase 2NCT05913414
Iron Isomaltide for Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma
A Phase 2 study testing Iron Isomaltoside 1000, Polysaccharide Iron Complex Pill and Intensity-modulated radiotherapy in people with Nasopharyngeal Carcinoma and Iron-deficiency, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, Iron-deficiency, Anemia
- What is being tested?
- Iron Isomaltoside 1000, Polysaccharide Iron Complex Pill and Intensity-modulated radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2023to 30 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Haiqiang Mai, MD,Ph.D, 86-20-8734-3643, maihq@mail.sysu.edu.cn
Qiuyan Chen, MD,Ph.D, 86-20-8734-3380, chenqy@mail.sysu.edu.cn
About this study
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
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.
Read the 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.
- Conditions
- Nasopharyngeal Carcinoma, Iron-deficiency, Anemia
- Being tested
- Iron Isomaltoside 1000, Polysaccharide Iron Complex Pill, Intensity-modulated radiotherapy
- Keywords
- Nasopharyngeal Carcinoma, iron-deficiency anemia
- Medical subject headings
- Nasopharyngeal Carcinoma, Anemia, Iron-Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Isomaltoside 1000Drug
Also called Iron isomaltoside
Patients receive Iron isomaltoside after IC and CCRT
Polysaccharide Iron Complex PillDrug
Patients receive Polysaccharide Iron Complex Pill after IC and CCRT
Intensity-modulated radiotherapyRadiation
All patients received intensity-modulated radiotherapy before enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Iron Isomaltide | Experimental | Patients receive iron Isomaltide after anti-tumor therapy. Receives: Drug: Iron Isomaltoside 1000; Radiation: Intensity-modulated radiotherapy |
| Oral iron supplement | Active comparator | Patients receive polysaccharide iron complex after anti-tumor therapy. Receives: Drug: Polysaccharide Iron Complex Pill; Radiation: Intensity-modulated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematopoietic response rate
Hematopoietic response rate at one month after IC+CCRT.
Measured: 1 month
Secondary outcomes (7)
Hematopoietic response rate
Hematopoietic response rate at two months after IC+CCRT.
Measured: 2 month
Hematopoietic response rate
Hematopoietic response rate at three months after IC+CCRT.
Measured: 3 month
Acute side effects
The acute side effects of iron isomaltide
Measured: 1 month
Quality of life scores
The scores of each scale of quality of life questionaires for FACT-An
Measured: 1 month
The difference of HGB
The difference of HGB after patients receiving iron supplements
Measured: 1,2,3 months
The score of concise fatigue scale
Calculated by Concise fatigue scale
Measured: 1,2,3 months
The difference of serum iron
The difference of HGB after patients receiving iron supplements
Measured: 1,2,3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start5 May 2023
- Primary completion30 May 2024 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hai-Qiang Mai,MD,PhD, Sun Yat-sen University
- Investigators
- Shan Shan Guo, Dr, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913414
- Sponsor's protocol ID
- 2022-747-01
- Status last verified
- Jun 2023
- First submitted
- 23 Apr 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05913414
- Acronym / sponsor ID
- 2022-747-01
- Conditions
- Nasopharyngeal Carcinoma, Iron-deficiency, Anemia
- Keywords
- Nasopharyngeal Carcinoma, iron-deficiency anemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron Isomaltide | Experimental | Drug: Iron Isomaltoside 1000, Radiation: Intensity-modulated radiotherapyPatients receive iron Isomaltide after anti-tumor therapy. |
| Oral iron supplement | Active comparator | Drug: Polysaccharide Iron Complex Pill, Radiation: Intensity-modulated radiotherapyPatients receive polysaccharide iron complex after anti-tumor therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron Isomaltoside 1000Also: Iron isomaltosidePatients receive Iron isomaltoside after IC and CCRT | Drug | Iron Isomaltide |
| Polysaccharide Iron Complex PillPatients receive Polysaccharide Iron Complex Pill after IC and CCRT | Drug | Oral iron supplement |
| Intensity-modulated radiotherapyAll patients received intensity-modulated radiotherapy before enrolled. | Radiation | Iron Isomaltide, Oral iron supplement |
Primary outcome
Hematopoietic response rate
Time frame: 1 month
Hematopoietic response rate at one month after IC+CCRT.
7 secondary outcomes
Hematopoietic response rate
Time frame: 2 month
Hematopoietic response rate
Time frame: 3 month
Acute side effects
Time frame: 1 month
Quality of life scores
Time frame: 1 month
The difference of HGB
Time frame: 1,2,3 months
The score of concise fatigue scale
Time frame: 1,2,3 months
The difference of serum iron
Time frame: 1,2,3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shan Shan Guo, Dr principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iron Isomaltoside 1000, Polysaccharide Iron Complex Pill and Intensity-modulated radiotherapy in people with Nasopharyngeal Carcinoma and Iron-deficiency, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiu Yan Chen, Dr (020-87343380, chenqy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematopoietic response rate (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.