Standardized nutrition treatment to improve nutrition and outcomes in advanced nasopharyngeal cancer with malnutrition

Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition: A Prospective, Multicenter, Phase III Randomized Control Clinical Trial

This trial tests whether a standardized nutrition program during chemoradiation helps adults (18–65) with locally advanced nasopharyngeal cancer who have malnutrition.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 266 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT04436965 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, phase III trial compares a standardized nutrition therapy program with conventional nutrition care in patients with locally advanced nasopharyngeal carcinoma and malnutrition. Participants are adults 18–65 with newly diagnosed WHO II/III NPC stage III–IVa who will receive cisplatin and intensity-modulated radiotherapy. The intervention arm receives protocolized, standardized nutritional support during treatment while the control arm receives usual nutrition management, with follow-up to measure nutritional status and clinical outcomes. Eligibility requires adequate organ function and performance status, and the trial is run at major cancer centers in China.

Who should consider this trial

Good fit: Ideal candidates are adults 18–65 with newly diagnosed, untreated WHO II/III nasopharyngeal carcinoma, clinical stage III–IVa, KPS ≥ 80, adequate organ function, and signs of malnutrition.

Not a fit: Patients who are not malnourished, are older than the eligible age range, have poor performance status, major organ failure, contraindications to enteral nutrition (e.g., PEG/PEJ issues), or prior anti-tumor treatment are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the intervention could improve patients' nutritional status during treatment and lead to better treatment tolerance and potentially improved clinical outcomes.

How similar studies have performed: Nutritional support has shown improved treatment tolerance and some outcome benefits in head and neck cancer studies, but large randomized Phase III evidence specifically in nasopharyngeal carcinoma is limited.

Eligibility criteria

Inclusion Criteria:

* Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III);
* All genders，range from 18～65 years old;
* Karnofsky performance status(KPS) ≥ 80;
* Clinical stage III\~IVa(AJCC/UICC 8th);
* Without significant digestive system disease，nutritional and metabolic diseases or endocrine disease
* Without significant cardiac，respiratory，kidney or liver disease;
* 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) ≥ 9g/L, platelet(PLT) count ≥ 100×109/L
* Total bilirubin(TBIL)、alanine aminotransferase (ALT) or aspartate aminotransferase(AST) \< 2.5×upper limit of normal(ULN);
* Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
* No contraindications to chemotherapy or radiotherapy;
* Inform consent form;

Exclusion Criteria:

* Have some PEG/PEJ contraindications, such as coagulopathy, recent anticoagulant medications and aspirin, gastric ulcer or history of gastric bleeding, portal hypertension combined with abdominal and esophageal fundal varices, pyloric obstruction due to residual stomach under the costal arch after various major gastrectomy or various reasons;
* Distance metastases;
* Have or are suffering from other malignant tumors;
* Participating in other clinical trials;
* Drug or alcohol addition;
* Do not have full capacity for civil acts;
* Mental disorder;
* Pregnancy or lactation;
* Severe complication, eg, uncontrolled hypertension;

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Chong Zhao, MD — Sun Yat-Sen University Cancer Center
• Study coordinator: Jingjing Miao, MD

Conditions Nasopharyngeal Carcinoma; Nutrition Therapy