Status:
UNKNOWN
Early Nutritional Intervention in NPC Patients Undergoing Concurrent Chemoradiotherapy
Lead Sponsor:
Guangdong Provincial People's Hospital
Conditions:
Malnutrition
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-74 years
Phase:
NA
Brief Summary
This single center, open-label, randomized controlled clinical trial was designed to investigate whether early nutritional intervention with oral nutrition supplements in patients with nasopharyngeal ...
Detailed Description
Concurrent chemoradiotherapy is the standard treatment for locally advanced nasopharyngeal carcinoma (NPC). During chemoradiotherapy, malnutrition is present in 44-88% patients which is associated wit...
Eligibility Criteria
Inclusion
- Pathologically confirmed nasopharyngeal carcinoma (NPC).
- The clinical stage of NPC is T1-4 N1-3 M0 (AJCC 7th edition).
- Planned to receive concurrent chemoradiotherapy with intensity-modulated radiation therapy (IMRT).
- Age ≥ 18 years and \< 75 years.
- Performance status (PS) score 0-1.
- NRS2002\<3 .
- Blood regular test should be satisfied the following conditions: white blood cell count ≥3.5×109/L， Neutrophil count ≥1.5×109/L，platelet count ≥100×109/L，hemoglobin ≥10g/L
- Liver and kidney functions test should be satisfied the following conditions: aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \< 2.5 times the upper limit of normal value, bilirubin \< 1.2 times the upper limit of normal value, creatinine \< 1.2 times the upper limit of normal value, and alkaline phosphatase \< 5 times the upper limit of normal value.
- Could complete required oral nutrition, questionnaire survey and follow-up.
- Signed informed consent voluntarily.
Exclusion
- Had a history of head and neck radiotherapy.
- Known allergic reaction to any component of ONS, or severe allergic constitution.
- With any unstable systemic disease (such as uncontrolled infectious diseases, uncontrolled hypertension, uncontrolled metabolic diseases and so on).
- Serious cardiovascular diseases in 6 months (such as Congestive heart failure and myocardial infarction).
- Pregnancy and lactation.
- Other conditions that the investigators consider as inappropriate for enrolling into this study.
- Has a history of malignant tumors in 5 years, except for tumors that have been cured only by surgery and with a disease free survival for five years, cured basal cell carcinoma of skin and cured carcinoma in situ of the cervix.
Key Trial Info
Start Date :
July 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT04810936
Start Date
July 26 2019
End Date
December 31 2022
Last Update
March 23 2021
Active Locations (1)
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1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080