Nutritional management during chemoradiotherapy for nasopharyngeal cancer

Nutritional Management During Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma Has an Impact on Immunonutritional Status and Therapeutic Phase Toxicity and Prognostic Effects

This study will test whether an immune‑enhancing oral nutritional supplement given throughout concurrent chemoradiotherapy helps adults with stage II–IVa nasopharyngeal cancer maintain weight, preserve lymphocyte counts, and reduce treatment side effects.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 109 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jiangxi Provincial Cancer Hospital (Academic / other)
• Locations: 1 site (Nanchang, Jiangxi)
• Trial ID: NCT07085988 on ClinicalTrials.gov

What this trial studies

This phase 2 interventional study at Jiangxi Cancer Hospital gives an immune‑enhancing oral nutritional preparation to adults with histologically confirmed stage II–IVa nasopharyngeal carcinoma who are receiving definitive concurrent chemoradiotherapy. Participants receive nutritional support by mouth or enterally throughout the course of chemoradiotherapy while investigators monitor weight, PG‑SGA scores, lymphocyte counts, and treatment‑related acute toxicities. Eligibility requires adequate performance status, blood counts, and liver and kidney function, and excludes patients with a second primary tumor, uncontrolled metabolic disease, or known allergy to the supplement. The main aim is to see if continuous nutritional management can reduce the severity and delay the onset of acute side effects while preserving nutritional and immune status during therapy.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed stage II–IVa nasopharyngeal carcinoma scheduled for concurrent chemoradiotherapy, with PG‑SGA 0–8, acceptable performance status and laboratory values, and able to take oral or enteral nutrition are ideal candidates.

Not a fit: Patients with a second primary tumor, uncontrolled diabetes or severe endocrine/metabolic disorders, those not receiving concurrent chemoradiotherapy, or those allergic to the nutritional formula are unlikely to benefit.

Why it matters

Potential benefit: If successful, the supplement could help patients keep weight and immune function during chemoradiotherapy and lessen or delay acute treatment side effects.

How similar studies have performed: Previous studies of immune‑enhancing nutritional supplements in head and neck cancers have reported improvements in weight and some immune markers, but results have been mixed and higher‑quality evidence remains limited.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Nanchang, Jiangxi

• Jiangxi Cancer Hospital — Nanchang, Jiangxi, China (Recruiting)

Study contacts

• Study coordinator: Yong Su, MD

Conditions Nasopharyngeal Carcinoma; Concurrent chemoradiotherapy; Immunonutrition Lymphocyte count