Back to resultsA Research About Nutrition Impact for Local Advanced Nasopharyngeal Carcinoma Patients
Primary Purpose
Malignant Neoplasm of Nasopharynx
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Nutrison
Sponsored by
About this trial
This is an interventional supportive care trial for Malignant Neoplasm of Nasopharynx focused on measuring nasopharyngeal carcinoma, intensity-modulated radiotherapy, nutrition support, nutrition assessment
Eligibility Criteria
Inclusion Criteria:
- Histologically conformed Initial nasopharyngeal carcinoma
- Patients can feed through the mouth.
- ECOG (Eastern Cooperative Oncology Group) : 0-2.
- No history of chemo-radiotherapy, immuno-therapy or biotherapy.
- 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).
- Informed consent signed.
Exclusion Criteria:
- History of malignant tumors.
- Any severe complications contraindicated chemotherapy or radiotherapy.
- Medical history of central nervous system, cognitive or psychological diseases;
- Pregnant or nursing women.
- Patients with mental disease cannot complete the questionaire.
- Patients refused the informed consent.
Sites / Locations
- Zhejiang Cancer Hosptial
- Zhejiang Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nutrition support
Regular diet
Arm Description
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.
Regular diet without other nutritional intervention.
Outcomes
Primary Outcome Measures
Overall survival
From the first treatment to the death of any causes
Secondary Outcome Measures
Progress free survival
From the first treatment to the progress of diseases
Full Information
NCT ID
NCT02948699
First Posted
October 21, 2016
Last Updated
November 30, 2018
Sponsor
Zhejiang Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02948699
Brief Title
A Research About Nutrition Impact for Local Advanced Nasopharyngeal Carcinoma Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
October 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Neoplasm of Nasopharynx
Keywords
nasopharyngeal carcinoma, intensity-modulated radiotherapy, nutrition support, nutrition assessment
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutrition support
Arm Type
Experimental
Arm Description
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.
Arm Title
Regular diet
Arm Type
No Intervention
Arm Description
Regular diet without other nutritional intervention.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrison
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall survival
Description
From the first treatment to the death of any causes
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Progress free survival
Description
From the first treatment to the progress of diseases
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Histologically conformed Initial nasopharyngeal carcinoma
Patients can feed through the mouth.
ECOG (Eastern Cooperative Oncology Group) : 0-2.
No history of chemo-radiotherapy, immuno-therapy or biotherapy.
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).
Informed consent signed.
Exclusion Criteria:
History of malignant tumors.
Any severe complications contraindicated chemotherapy or radiotherapy.
Medical history of central nervous system, cognitive or psychological diseases;
Pregnant or nursing women.
Patients with mental disease cannot complete the questionaire.
Patients refused the informed consent.
Facility Information:
Facility Name
Zhejiang Cancer Hosptial
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Research About Nutrition Impact for Local Advanced Nasopharyngeal Carcinoma Patients
We'll reach out to this number within 24 hrs