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

NCT03344068 | Unknown Phase 2 DMC

• 1 other identifier: B2017-055-01
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

nasopharyngeal carcinoma; nutritional support; early and whole course; efficacy and safety

Outcome Measures

Primary Outcomes (1)

• Decline in nutritional status needed upgrading nutritional intervention

  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 Outcomes (5)

• Quality of life

  3 months after radiotherapy

• Moderate and severe bone marrow depression and anemia

  3 months after radiotherapy

• Severe oral mucositis

  3 months after radiotherapy

• Interruption rate of radiotherapy and/or chemotherapy caused by intolerance

  3 months after radiotherapy

• Complete remission

  3 months after radiotherapy

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Radiation: Radiotherapy; Drug: Chemotherapy; Dietary Supplement: Nutren® Optimum

Controlled Group

ACTIVE COMPARATOR

The patients in the Controlled Group are allocated to receive radical radiotherapy with or without chemotherapy plus routine diet guidance at begin of radiotherapy.

Radiation: Radiotherapy; Drug: Chemotherapy

Interventions

Radiotherapy RADIATION

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

Controlled Group; Experimental Group

Chemotherapy DRUG

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

Controlled Group; Experimental Group

Nutren® Optimum DIETARY_SUPPLEMENT

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

Experimental Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Nestle Health Science: collaborator

Study Sites (1)

Department of Radiation Oncology, Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Radiotherapy; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Yun-fei Xia, M.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun-fei Xia, M.D

CONTACT

86-13602805461; xiayf@sysucc.org.cn

Chen Chen, M.D

CONTACT

86-13570487011; chenchen@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The patients eligible are divided randomly. All the patients will receive radical radiotherapy with or without chemotherapy. The cases in the Experimental Group will receive Nutren® Optimum of 7 scoops tid at begin of radiotherapy.

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: November 17, 2017
• Study Start: January 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2021
• Last Updated: December 22, 2017

Record last verified: 2017-11

Locations

CN (1)