A Research About Nutrition Impact for Local Advanced Nasopharyngeal Carcinoma Patients

NCT ID: NCT02948699

Last Updated: 2018-12-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2019-10-31

Brief Summary

The chemo-radiotherapy for the local advanced nasopharyngeal carcinoma patients will induce the mucosal ulcer and damage salivary glands. Consequently, it can disturb the nutrition conditions and clinical outcomes of patients. This research tries to evaluate the nutrition status at the baseline, before and after radiotherapy, during the follow-up by the body mass index, hematological indexes, immunological indexes, and nutrition questionnaires including PG-SGA and NRS 2002. Through the evaluation of two different nutritional interventions, the investigators aim to find an optimized assessment model and the best nutrition support patterns.

Detailed Description

All nasopharyngeal patients received radical treatment including neo-adjuvant chemotherapy and concurrent chemo-radiotherapy. At the beginning, the investigators assign patient to experimental and control groups randomly. Patients in experimental group received standard nutritional support by adding NUTRISON. Control patients will give conventional nutritional guidance. The investigators collected all the nutritional indexed at first visit, before and after radiotherapy, 1, 3, 6, 9, 12 months after radiotherapy. All these data will be set into statistical software to produce an optimized model for clinical practice.

Conditions

Malignant Neoplasm of Nasopharynx

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Nutrition support

Nutrison was added to regular diet while the patients can be fed through mouth. Nutrison will replace regular diet by NG or PEG while the patients can not eat for serious oral mucositis.

Group Type: EXPERIMENTAL

Nutrison

Intervention Type: DIETARY_SUPPLEMENT

Nutrison(400-600ml/d) will be given to Arm 1 patient between regular diet. When the daily ration was cut down to 50%,100ml/h Nutrison was added. When grade Ⅲ-Ⅳ oral mucositis appeared, total Nutrison was applied to patients by NG or PEG.

Regular diet

Regular diet without other nutritional intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nutrison

Nutrison(400-600ml/d) will be given to Arm 1 patient between regular diet. When the daily ration was cut down to 50%,100ml/h Nutrison was added. When grade Ⅲ-Ⅳ oral mucositis appeared, total Nutrison was applied to patients by NG or PEG.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Histologically conformed Initial nasopharyngeal carcinoma

2. Patients can feed through the mouth.

3. ECOG (Eastern Cooperative Oncology Group) : 0-2.

4. No history of chemo-radiotherapy, immuno-therapy or biotherapy.

5. Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function).

6. Informed consent signed.

Exclusion Criteria

1. History of malignant tumors.

2. Any severe complications contraindicated chemotherapy or radiotherapy.

3. Medical history of central nervous system, cognitive or psychological diseases;

4. Pregnant or nursing women.

5. Patients with mental disease cannot complete the questionaire.

6. Patients refused the informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhejiang Cancer Hosptial

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

NPC-NUTR-2016

Identifier Type: -

Identifier Source: org_study_id