Early and Whole Course Nutritional Support by Nutren® Optimum During IMRT for Nasopharyngeal Carcinoma

• Status: Unknown status
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: All

Summary

Radiation therapy remains the principal treatment for nasopharyngeal carcinoma (NPC). The most frequently occurred radiation-related side effect is probably the radiation-induced oral mucositis, which affects up to 100% of NPC patients receiving radiation therapy, especially combined with chemotherapy. Significant weight loss caused by Oral mucositis will keep patients in worse nutrition status and then to decline immune function, hematopoietic function and repair function, which will influence the patient's quality of life, reduce the tolerance of treatment, and affect treatment effect. At present, the guidelines at home and abroad more and more emphasize that early nutrition treatment and intervention before systemic malnutrition, also suggest nutrition treatment and intervention at the same time of anti-tumor treatment. First choice of nutritional intervention is oral nutrition supplement. Nutren® Optimum has a higher protein ratio and 50% of the protein sources were lactalbumin and 50% casein. Lactalbumin is a high-quality protein, with the highest nutritional value among a variety of proteins. A cup of 210ml's Nutren® Optimum contains 5g lactalbumin. Nutren® Optimum also contains dietary fiber, vitamin E, monounsaturated fat, L-carnitine, 30 kinds of vitamins and minerals and other nutrients, which can provide a comprehensive and balanced nutrition. This single center, open-label, randomized controlled clinical trial selects Nutren® Optimum as oral nutritional support for interventional group while routine diet guidance for control group, aiming to evaluate the efficacy and safety of early and whole course nutritional support by Nutren® Optimum during intensity modulated radiation therapy for nasopharyngeal carcinoma which can improve patients' nutritional state and quality of life, reduce side effects and improve the tolerability and effectiveness of antitumor treatment.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Nestle Health Science (China) Ltd.; Nestlé Health Science Spain

Criteria

Inclusion Criteria:

• Pathologically confirmed and previously untreated nasopharyngeal carcinoma without distant metastasis.

• Age ≥ 18 years and < 65 years.

• Karnofsky performance status (KPS) score ≥ 70.

• Planned to receive radiotherapy alone or concurrent chemoradiotherapy, with intensity-modulated radiation therapy (IMRT).

• Adequate normal organ function.

• Well nutritional status, with PG-SGA≤1 score and NRS2002<3 scores.

• Without other severe diseases.

• Signed informed consent voluntarily, and could complete required oral nutrition, questionnaire survey and follow-up.

Exclusion Criteria:

• Known allergic reaction to any component of Nutren® Optimum, or severe allergic constitution.

• Poor compliance.

• Other conditions that the investigators consider as inappropriate for enrolling into this study.