Status:
COMPLETED
Effect of Oral Nutritional Supplements on Body Weight Loss of Patients With Nasopharyngeal Carcinoma
Lead Sponsor:
Jinsheng Hong
Collaborating Sponsors:
Fujian Cancer Hospital
The Second Affiliated Hospital of Fujian Medical University
Conditions:
Nasopharyngeal Carcinoma
Nutritional Support
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Concurrent chemoradiotherapy(CCRT) is the principal treatment for nasopharyngeal carcinoma(NPC). Studies have shown that malnutrition is very common in patients with NPC after chemoradiotherapy. Malnu...
Eligibility Criteria
Inclusion
- Newly histologic diagnosis of nasopharyngeal carcinoma;
- All genders, range from 18-70 years old;
- Clinical stage II-IVa according to the 8th edition of the Union for International Cancer Control/American Joint Committee on Cancer (UICC/AJCC) staging system;
- Patient-Generated Subjective Nutrition Assessment (PG-SGA) score ≤8;
- Main organ functions test should be satisfied the following conditions: (1) Absolute neutrophil count (ANC) ≥1.5×10\^9/L; (2) Platelet (PLT) ≥80×10\^9/L; (3) Hemoglobin (Hb) ≥90 g/L; (4) Bilirubin \< 1.5 times the upper limit of normal value (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 times the upper limit of normal value; (5) Creatinine \< 1.5 times the upper limit of normal value or creatinine clearance rate \>60 ml/min.
Exclusion
- Patients whose energy intake is less than 60% of the target energy requirement for 3 days or more;
- Have or are suffering from other malignant tumors;
- Refuse concurrent chemoradiotherapy;
- With diabetics, galactosemia, or sever metabolic diseases or endocrine diseases;
- Cannot take oral or enteral nutrition, including intestinal obstruction, severe short bowel syndrome or high output fistula, or with severe digestive system diseases;
- Known allergic reaction to any component of Abbott®Ensure, or severe allergic constitution;
- Pregnant or lactating women;
- With previous or ongoing clinical trials;
- Refuse to sign inform consent form.
Key Trial Info
Start Date :
July 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2025
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT04823468
Start Date
July 19 2021
End Date
May 15 2025
Last Update
June 10 2025
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
2
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
3
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
4
900th hospital of the joint logistics team, PLA
Fuzhou, Fujian, China, 350025