A Research About Nutrition Impact for Local Advanced Nasopharyngeal Carcinoma Patients

Malignant Neoplasm of Nasopharynx Clinical Trial

Official title:

A Prospective, Randomized Controlled Open Research About the Impact of Nutritional Support on the Radiation Tolerance and Clinical Outcomes for Local Advanced Nasopharyngeal Carcinoma Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02948699
• Other study ID #: NPC-NUTR-2016
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: November 2016
• Est. completion date: October 2019

Study information

• Verified date: November 2018
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 114
• Est. completion date: October 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Malignant Neoplasm of Nasopharynx
• Nasopharyngeal Neoplasms
• Neoplasms

Intervention

Dietary Supplement:
• 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 ?-? oral mucositis appeared, total Nutrison was applied to patients by NG or PEG.

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Zhejiang Cancer Hosptial	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	From the first treatment to the death of any causes	5 years
Secondary	Progress free survival	From the first treatment to the progress of diseases	5 years