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

December 21, 2017 updated by: Yun-fei Xia, Sun Yat-sen University

A Single Center, Open-label, Randomized Controlled Clinical Trial on the Early and Whole Course Nutritional Support by Nutren® Optimum During Intensity Modulated Radiation Therapy for Nasopharyngeal Carcinoma

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.

Study Overview

Detailed Description

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.

Oral mucositis is just the most common cause of significant weight loss for patients with nasopharyngeal carcinoma during treatment. Patients with oral mucositis will have restriction of normal food, and alternative to semi liquid or liquid diet, resulting in inadequate nutritional intake, malnutrition, weight loss. Furthermore, worse nutrition status will 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. Therefore, the timing of nutritional intervention changes from ineffective antitumor therapy as a palliative treatment to the early start of antitumor therapy. For nasopharyngeal carcinoma, early and whole course nutritional intervention can prevent and treat malnutrition or cachexia; improve the treatment tolerance and compliance; control or improve certain adverse reactions of radiotherapy; improve the quality of life; and then improve the function and curative effect. First choice of nutritional intervention is oral nutrition supplement. For patients without gastrointestinal dysfunction, parenteral nutrition is not necessary, even harmful, increasing the risk of infection.

Nutren® Optimum has a higher protein ratio (P:F:C = 17:35:48), and 50% of the protein sources were lactalbumin and 50% casein. Lactalbumin is a high-quality protein, which dissolved and dispersed in the whey protein. Lactalbumin is easy digestion and absorption, with high bioavailability, and net protein utilization rate (NPU) is higher than that of casein and soy protein. Lactalbumin is rich in branched chain amino acids, which can be used as energy material for energy. Lactalbumin has a sulfur-containing amino acid, which can maintain the level of GSH and be in the role of antioxidation; containing glutamine, which contributes to muscle glycogen update and improves immune function. In addition, lactalbumin can also significantly reduce neutrophil apoptosis, enhance neutrophil migration and phagocytosis, and enhance the immune function. Therefore, lactalbumin has the highest nutritional value among a variety of proteins, known as protein king. A cup of 210ml's Nutren® Optimum contains 5g lactalbumin.

Nutren® Optimum contains dietary fiber, which produces short chain fatty acids to promote the proliferation of intestinal probiotics, and play anti-inflammatory, pro-apoptotic, anti-tumor effect, and maintain intestinal health. At the same time, vitamin E is specially added in Nutren® Optimum to protect T lymphocytes, protect red blood cells, anti-oxidation, inhibit platelet aggregation, enhance immunity, and so on. In addition, 64% fat sources of Nutren® Optimum are monounsaturated fat, which conducive to the metabolism of glucose and lipid. Especially added L-carnitine can promote fat oxidation by using better fat for energy, without reducing water and muscle. Nutren® Optimum provides 30 kinds of vitamins and minerals and other nutrients, and 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.

Study Type

Interventional

Enrollment (Anticipated)

408

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Department of Radiation Oncology, Sun Yat-Sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
The patients in the Experimental Group are allocated to receive radical radiotherapy with or without chemotherapy plus Nutren® Optimum of 7 scoops tid at begin of radiotherapy.
Intensity Modulated Radiation Therapy, Dose: GTVnx 6810cGy/30Fr, GTVnd 6400-6600cGy/30Fr, CTV1 6000cGy, CTV2 5400cGy.
Nedaplatin 80mg/m2 d1+5-fluouracil 500mg/m2 d2-5, every 3 weeks; a total of 2-3 cycles.
Nutren® Optimum, 7 scoops each time, three times a day, at begin of radiotherapy
Active Comparator: Controlled Group
The patients in the Controlled Group are allocated to receive radical radiotherapy with or without chemotherapy plus routine diet guidance at begin of radiotherapy.
Intensity Modulated Radiation Therapy, Dose: GTVnx 6810cGy/30Fr, GTVnd 6400-6600cGy/30Fr, CTV1 6000cGy, CTV2 5400cGy.
Nedaplatin 80mg/m2 d1+5-fluouracil 500mg/m2 d2-5, every 3 weeks; a total of 2-3 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decline in nutritional status needed upgrading nutritional intervention
Time Frame: 3 months after radiotherapy
The percentage of patients whose body weight decreased by 5% over baseline, or the PG-SGA score was more than 8, or the NRS2002 score was more than 3.
3 months after radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 3 months after radiotherapy
The standard scores assessed by EORTC QOL scale decreased by more than 10 points
3 months after radiotherapy
Moderate and severe bone marrow depression and anemia
Time Frame: 3 months after radiotherapy
Incidence of 3-4 degrees bone marrow depression and anemia according to CTCAE (version 4)
3 months after radiotherapy
Severe oral mucositis
Time Frame: 3 months after radiotherapy
Incidence of 3-4 degrees oral mucositis according to CTCAE (version 4)
3 months after radiotherapy
Interruption rate of radiotherapy and/or chemotherapy caused by intolerance
Time Frame: 3 months after radiotherapy
The percentage of patients whose radiotherapy and/or chemotherapy were interrupted by treatment-related toxicity intolerance
3 months after radiotherapy
Complete remission
Time Frame: 3 months after radiotherapy
The percentage of patients whose all the target lesions disappeared, no new lesions appeared according to RECIST
3 months after radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Yun-fei Xia, M.D, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

March 31, 2021

Study Registration Dates

First Submitted

October 25, 2017

First Submitted That Met QC Criteria

November 14, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

December 22, 2017

Last Update Submitted That Met QC Criteria

December 21, 2017

Last Verified

November 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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