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

NCT03344068 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2017-12-22

No results posted yet for this study

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.

Conditions

  • Nasopharyngeal Carcinoma
  • Nutritional Support

Interventions

RADIATION

Radiotherapy

Intensity Modulated Radiation Therapy, Dose: GTVnx 6810cGy/30Fr, GTVnd 6400-6600cGy/30Fr, CTV1 6000cGy, CTV2 5400cGy.

DRUG

Chemotherapy

Nedaplatin 80mg/m2 d1+5-fluouracil 500mg/m2 d2-5, every 3 weeks; a total of 2-3 cycles.

DIETARY_SUPPLEMENT

Nutren® Optimum

Nutren® Optimum, 7 scoops each time, three times a day, at begin of radiotherapy

Sponsors & Collaborators

  • Nestle Health Science

    collaborator INDUSTRY

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Yun-fei Xia, M.D · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2020-12-31
Completion
2021-03-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03344068 on ClinicalTrials.gov