Nasopharyngeal Carcinoma (NPC)Phase 2NCT07085988
Effect of Nutritional Management on Patients With Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma
A Phase 2 study testing Rapid glitter in people with Nasopharyngeal Carcinoma (NPC), run by Jiangxi Provincial Cancer Hospital at 1 site in China.
Trial summary
Nasopharyngeal carcinoma (NPC) is a malignant tumor that develops in the nasopharyngeal mucosal epithelium. Due to the disease itself and the impact of anti-tumor therapy, malnutrition has become a common clinical complication in patients with NPC, among which NPC patients receiving concurrent chemoradiotherapy are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- Rapid glitter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Patients with nasopharyngeal carcinoma confirmed by histopathology;2.Clinical stage stage II-IVa,Concurrent chemoradiotherapy is included in the definitive treatment regimen;3.Age ≥ 18 years, male or female;4.PG-SGA score of 0-8 before radiotherapy;5.KPS score ≥ 60 or ECOG score ≤3;6.Nutritional supplementation can be given by mouth or enterally;7.Patients sign a formal informed consent form to indicate that they understand that this study complies with hospital policies;8.Serum hemoglobin ≥ 90 g/L, platelet ≥ 100×109/L, absolute neutrophil count ≥ 1.5×109/L;9.serum creatinine ≤1.25 times ULN or creatinine clearance ≥60 mL/min;10.Serum bilirubin ≤ 1.5-fold ULN, AST (SGOT) and ALT (SGPT) ≤ 2.5-fold ULN, and alkaline phosphatase ≤ 5-fold ULN.
Who cannot join
- 1.Have a second primary tumor;2.Those who do not receive concurrent chemoradiotherapy;3.Comorbid diabetes mellitus, or history of severe endocrine and metabolic diseases;4.Those who are allergic to oral nutritional meal replacements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi
yong Su, MD, CHINA/360100+13699526170, 1246256523@qq.com
About this study
Official title: Nutritional Management During Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma Has an Impact on Immunonutritional Status and Therapeutic Phase Toxicity and Prognostic Effects
Nasopharyngeal carcinoma (NPC) is a malignant tumor that develops in the nasopharyngeal mucosal epithelium. Due to the disease itself and the impact of anti-tumor therapy, malnutrition has become a common clinical complication in patients with NPC, among which NPC patients receiving concurrent chemoradiotherapy are one of the groups with the highest incidence of malnutrition, and malnutrition seriously affects the prognosis of NPC patients. Nutritional management throughout the course has a positive impact on the prognosis and life management of NPC patients. As an immune-enhancing oral nutritional preparation, it is helpful to maintain the weight and immune function of patients with nasopharyngeal carcinoma during concurrent chemoradiotherapy, reduce the degree of treatment-related side effects during concurrent chemoradiotherapy for nasopharyngeal carcinoma, and delay the occurrence of acute side effects. The purpose of this study was to investigate the effect of rapid rapid rapid improvement of patients' immune status during concurrent chemoradiotherapy, and to further evaluate its impact on patients' weight, prognosis, treatment-related toxic side effects, and quality of life. In this study, 109 patients with nasopharyngeal carcinoma who received concurrent chemoradiotherapy in our hospital are planned to be included, and all patients in this group will be given oral tachyphin at a standard dose from the first day of radiotherapy. The nutritional immune status of the patient was assessed at different points during the treatment period.
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Being tested
- Rapid glitter
- Keywords
- Nasopharyngeal Carcinoma, Concurrent chemoradiotherapy, Immunonutrition Lymphocyte count
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid glitterOther
Patients with nasopharyngeal carcinoma are given rapid gamin during concurrent chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Effect of nutritional management in patients with nasopharyngeal carcinoma | Experimental | Patients with nasopharyngeal carcinoma are given rapid gamin during concurrent chemoradiotherapy Receives: Other: Rapid glitter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased proportion of immune cell subsets
The proportion of immune cell subsets that decline during chemoradiotherapy, including CD3, CD4, CD8
Measured: 2 weeks
Secondary outcomes (2)
Change in the patient's weight
Change in the patient's weight during concurrent chemoradiotherapy
Measured: 2 weeks
Disease Free Survival
DFS was defined as the interval from the date of diagnosis to the data of disease recurrence or death DFS was defined as the interval from the date of diagnosis to the data of disease recurrence or death DFS was defined as the interval from the date of diagnosis to the data of disease recurrence or death
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085988
- Sponsor's protocol ID
- Jiangxi Cancer Hospital
- Status last verified
- Jul 2025
- First submitted
- 7 Apr 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Management During Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma Has an Impact on Immunonutritional Status and Therapeutic Phase Toxicity and Prognostic Effects
- ClinicalTrials.gov ID
- NCT07085988
- Acronym / sponsor ID
- Jiangxi Cancer Hospital
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Keywords
- Nasopharyngeal Carcinoma, Concurrent chemoradiotherapy, Immunonutrition Lymphocyte count
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- Jiangxi Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Jul 2025 (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.
Nasopharyngeal carcinoma (NPC) is a malignant tumor that develops in the nasopharyngeal mucosal epithelium. Due to the disease itself and the impact of anti-tumor therapy, malnutrition has become a common clinical complication in patients with NPC, among which NPC patients receiving concurrent chemoradiotherapy are one of the groups with the highest incidence of malnutrition, and malnutrition seriously affects the prognosis of NPC patients. Nutritional management throughout the course has a positive impact on the prognosis and life management of NPC patients. As an immune-enhancing oral nutritional preparation, it is helpful to maintain the weight and immune function of patients with nasopharyngeal carcinoma during concurrent chemoradiotherapy, reduce the degree of treatment-related side effects during concurrent chemoradiotherapy for nasopharyngeal carcinoma, and delay the occurrence of acute side effects. The purpose of this study was to investigate the effect of rapid rapid rapid improvement of patients' immune status during concurrent chemoradiotherapy, and to further evaluate its impact on patients' weight, prognosis, treatment-related toxic side effects, and quality of life. In this study, 109 patients with nasopharyngeal carcinoma who received concurrent chemoradiotherapy in our hospital are planned to be included, and all patients in this group will be given oral tachyphin at a standard dose from the first day of radiotherapy. The nutritional immune status of the patient was assessed at different points during the treatment period.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effect of nutritional management in patients with nasopharyngeal carcinoma | Experimental | Other: Rapid glitterPatients with nasopharyngeal carcinoma are given rapid gamin during concurrent chemoradiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Patients with nasopharyngeal carcinoma confirmed by histopathology;2.Clinical stage stage II-IVa,Concurrent chemoradiotherapy is included in the definitive treatment regimen;3.Age ≥ 18 years, male or female;4.PG-SGA score of 0-8 before radiotherapy;5.KPS score ≥ 60 or ECOG score ≤3;6.Nutritional supplementation can be given by mouth or enterally;7.Patients sign a formal informed consent form to indicate that they understand that this study complies with hospital policies;8.Serum hemoglobin ≥ 90 g/L, platelet ≥ 100×109/L, absolute neutrophil count ≥ 1.5×109/L;9.serum creatinine ≤1.25 times ULN or creatinine clearance ≥60 mL/min;10.Serum bilirubin ≤ 1.5-fold ULN, AST (SGOT) and ALT (SGPT) ≤ 2.5-fold ULN, and alkaline phosphatase ≤ 5-fold ULN.
Key exclusion criteria (1 listed)
- 1.Have a second primary tumor;2.Those who do not receive concurrent chemoradiotherapy;3.Comorbid diabetes mellitus, or history of severe endocrine and metabolic diseases;4.Those who are allergic to oral nutritional meal replacements.
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 |
|---|---|---|
| Rapid glitterPatients with nasopharyngeal carcinoma are given rapid gamin during concurrent chemoradiotherapy | Other | Effect of nutritional management in patients with nasopharyngeal carcinoma |
Primary outcome
Decreased proportion of immune cell subsets
Time frame: 2 weeks
The proportion of immune cell subsets that decline during chemoradiotherapy, including CD3, CD4, CD8
2 secondary outcomes
Change in the patient's weight
Time frame: 2 weeks
Disease Free Survival
Time frame: 3 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- 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.
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 Rapid glitter in people with Nasopharyngeal Carcinoma (NPC), run by Jiangxi Provincial Cancer Hospital 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 25 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Su, MD (CHINA/360100+13699526170, 1246256523@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased proportion of immune cell subsets (time frame: 2 weeks). 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 25 Jul 2025.