Nasopharyngeal CarcinomaNCT03240835
The Function of PA, RBP and TRSF in Malnutrition Detecting and Nutritional Status Monitoring for NPC Patients
An observational study of Nasopharyngeal Carcinoma and Malnutrition, run by Zhao Chong at 1 site in China.
Trial summary
The purpose of this study is to study the function of pre-albumin, retinol conjugated protein and transferrin in early malnutrition detecting and nutritional status dynamic monitoring for local advanced nasopharyngeal carcinoma patients with chemoradiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, Malnutrition
- What is being tested?
- cisplatin and docetaxel and IMRT
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2017to 31 Dec 2025
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: III-IVb(Union for International Cancer Control,UICC 8th) NPC patients with histologic diagnosis of World Health Organization(WHO) II/III
Who may be able to join
- Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)
- All genders，range from 18～60 years old
- Karnofsky performance status(KPS) ≥ 80
- Clinical stage III~IVb(UICC 8th)
- Without significant digestive system disease，nutritional and metabolic diseases or endocrine disease
- Without significant cardiac，respiratory，kidney or liver disease
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- Not received radiotherapy, chemotherapy and other anti-tumor treatment(including immunotherapy)
- white blood cell(WBC) count ≥ 4×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, Hemoglobin(HGB) ≥ 10g/L, platelet(PLT) count ≥ 100×109/L
- alanine aminotransferase (ALT) or aspartate aminotransferase(AST) < 1.5×upper limit of normal(ULN), bilirubin < 1.5×ULN, alanine aminotransferase (CCR) ≥ 30ml/min
- Inform consent form
Who cannot join
- Distance metastases
- Second malignancy within 5 years
- Drug or alcohol addition
- Do not have full capacity for civil acts
- Active systemic infections
- Chronic consumptions
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- Mental disorder
- Pregnancy or lactation
- Concurrent immunotherapy or hormone therapy for other diseases
- Severe complication, eg, uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Function of Pre-Albumin, Retinol Conjugated Protein and Transferrin in Early Malnutrition Detecting and Nutritional Status Dynamic Monitoring for Local Advanced Nasopharyngeal Carcinoma Patients With Chemoradiotherapy
The purpose of this study is to study the function of pre-albumin, retinol conjugated protein and transferrin in early malnutrition detecting and nutritional status dynamic monitoring for local advanced nasopharyngeal carcinoma patients with chemoradiotherapy.
- Conditions
- Nasopharyngeal Carcinoma, Malnutrition
- Being tested
- cisplatin and docetaxel, IMRT
- Keywords
- pre-Albumin, Retinol Conjugated Protein, Transferrin, Locoregionally Advanced Nasopharyngeal Carcinoma, nutrition
- Medical subject headings
- Nasopharyngeal Carcinoma, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatin and docetaxelDrug
NACt：cisplatin 75 mg/m2 intravenous infusion in day1，docetaxel 75 mg/m2 intravenous infusion in day1，both drugs are given every 3 weeks, two cycles.
CCRT: cisplatin (100mg/m2 on day 1) every three weeks for two cycles.
IMRTRadiation
intensity modulation radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| CCRT±NACT | Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin) , or treated with CCRT only Receives: Drug: cisplatin and docetaxel; Radiation: IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of PA/RBP/TRSF
to evaluate the changes of PA/RBP/TRSF during the treatment
Measured: baseline and during treatment
Secondary outcomes (3)
Change of Body weight
to compare the change of weight loss during treatment
Measured: baseline and during treatment
Number of Participants With Abnormal Laboratory Values
To observe the complete blood cell count and blood biochemical examination during treatment
Measured: baseline and during treatment
Acute Toxicity
To evaluate the acute toxicity with Common Terminology Criteria For Adverse Events (CTCAE) 4.0
Measured: baseline and during treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start12 Sep 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2025
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhao Chong
- Sponsor type
- University, hospital or other
- Collaborators
- Wu Jieping Medical Foundation
- Responsible party
- Sponsor-investigator, Zhao Chong, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240835
- Sponsor's protocol ID
- NPC-PA/RBP/TRSF
- Status last verified
- May 2026
- First submitted
- 27 Jul 2017
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Function of Pre-Albumin, Retinol Conjugated Protein and Transferrin in Early Malnutrition Detecting and Nutritional Status Dynamic Monitoring for Local Advanced Nasopharyngeal Carcinoma Patients With Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT03240835
- Acronym / sponsor ID
- NPC-PA/RBP/TRSF
- Conditions
- Nasopharyngeal Carcinoma, Malnutrition
- Keywords
- pre-Albumin, Retinol Conjugated Protein, Transferrin, Locoregionally Advanced Nasopharyngeal Carcinoma, nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zhao ChongUniversity, hospital or other
- Collaborators
- Wu Jieping Medical Foundation
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 7 Aug 2017 (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.
The purpose of this study is to study the function of pre-albumin, retinol conjugated protein and transferrin in early malnutrition detecting and nutritional status dynamic monitoring for local advanced nasopharyngeal carcinoma patients with chemoradiotherapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CCRT±NACT | – | Drug: cisplatin and docetaxel, Radiation: IMRTPatients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin) , or treated with CCRT only |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- III-IVb(Union for International Cancer Control,UICC 8th) NPC patients with histologic diagnosis of World Health Organization(WHO) II/III
Key inclusion criteria (10 listed)
- Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)
- All genders，range from 18～60 years old
- Karnofsky performance status(KPS) ≥ 80
- Clinical stage III~IVb(UICC 8th)
- Without significant digestive system disease，nutritional and metabolic diseases or endocrine disease
Key exclusion criteria (10 listed)
- Distance metastases
- Second malignancy within 5 years
- Drug or alcohol addition
- Do not have full capacity for civil acts
- Active systemic infections
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 |
|---|---|---|
| cisplatin and docetaxelNACt：cisplatin 75 mg/m2 intravenous infusion in day1，docetaxel 75 mg/m2 intravenous infusion in day1，both drugs are given every 3 weeks, two cycles. CCRT: cisplatin (100mg/m2 on day 1) every three weeks for two cycles. | Drug | CCRT±NACT |
| IMRTintensity modulation radiation therapy | Radiation | CCRT±NACT |
Primary outcome
changes of PA/RBP/TRSF
Time frame: baseline and during treatment
to evaluate the changes of PA/RBP/TRSF during the treatment
3 secondary outcomes
Change of Body weight
Time frame: baseline and during treatment
Number of Participants With Abnormal Laboratory Values
Time frame: baseline and during treatment
Acute Toxicity
Time frame: baseline and during treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma and Malnutrition, run by Zhao Chong 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 10 inclusion and 10 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: finished, as of the sponsor's last update on 7 May 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of PA/RBP/TRSF (time frame: baseline and during treatment). 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 7 May 2026.