Last updated: March 19, 2021
Sponsor: Guangdong Provincial People's Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Carcinoma
Weight Loss
Diet And Nutrition
Treatment
N/AClinical Study ID
NCT04810936
GDREC2018296H(R1)
Ages 18-74 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 radiationtherapy (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 cellcount ≥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 theupper 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 < 5times the upper limit of normal value.
- Could complete required oral nutrition, questionnaire survey and follow-up.
- Signed informed consent voluntarily.
Exclusion
Exclusion Criteria:
- 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 andmyocardial infarction).
- Pregnancy and lactation.
- Other conditions that the investigators consider as inappropriate for enrolling intothis study.
- Has a history of malignant tumors in 5 years, except for tumors that have been curedonly by surgery and with a disease free survival for five years, cured basal cellcarcinoma of skin and cured carcinoma in situ of the cervix.
Study Design
Total Participants: 272
Study Start date:
July 26, 2019
Estimated Completion Date:
December 31, 2022
Study Description
Connect with a study center
Guangdong Provincial People's Hospital
Guangzhou, Guangdong 510080
ChinaActive - Recruiting
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