Actively Recruiting
Nutritional Management During Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma: Impact on Immune Status, Treatment Toxicity, and Prognosis
Led by Jiangxi Provincial Cancer Hospital · Updated on 2025-07-25
109
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Nasopharyngeal carcinoma (NPC) is a cancer that develops in the lining of the nasopharynx. Malnutrition is a common complication in NPC patients, especially those receiving concurrent chemoradiotherapy, which can affect their prognosis. This trial is studying the impact of nutritional management on immune status, weight, treatment side effects, and quality of life in NPC patients undergoing concurrent chemoradiotherapy. Participants in this study will receive an immune-enhancing oral nutritional supplement called Rapid glitter starting from the first day of their radiotherapy. The study is designed to assess how this nutritional support affects patients during their chemoradiotherapy treatment course. The study is non-randomized and involves giving all patients the supplement while monitoring their condition. Throughout the treatment period, researchers will evaluate patients' immune nutritional status at various points. They will track changes in immune cell populations, weight, treatment-related toxicities, and quality of life. The primary outcome is the decrease in certain immune cell subsets after 2 weeks, with secondary outcomes including weight change at 2 weeks and disease-free survival over 3 years. Participants will be involved in regular assessments during and after treatment to monitor these outcomes.
CONDITIONS
Brief Title
Effect of Nutritional Management on Patients With Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with nasopharyngeal carcinoma confirmed by histopathology
- Clinical stage II-IVa and receiving concurrent chemoradiotherapy as part of definitive treatment
- Age 18 years or older, any gender
- PG-SGA score between 0 and 8 before radiotherapy
- KPS score 60 or higher or ECOG score 3 or lower
- Able to receive nutritional supplementation orally or enterally
- Signed informed consent form
- Serum hemoglobin 90 g/L or higher, platelet count 100 x 10^9/L or higher, absolute neutrophil count 1.5 x 10^9/L or higher
- Serum creatinine less than or equal to 1.25 times the upper limit of normal or creatinine clearance 60 mL/min or higher
- Serum bilirubin less than or equal to 1.5 times the upper limit of normal; AST and ALT less than or equal to 2.5 times the upper limit of normal; alkaline phosphatase less than or equal to 5 times the upper limit of normal
You will not qualify if you...
- Presence of a second primary tumor
- Not receiving concurrent chemoradiotherapy
- Comorbid diabetes mellitus or history of severe endocrine and metabolic diseases
- Allergy to oral nutritional meal replacements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks
Participants receive nutritional management during concurrent chemoradiotherapy for nasopharyngeal carcinoma.
Multiple visits during concurrent chemoradiotherapy
Trial Site Locations
Total: 1 location
1
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Actively Recruiting
Research Team
Y
Yong Su, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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