Clinical trial · Interventional
Early Nutritional Intervention in NPC Patients Undergoing Concurrent Chemoradiotherapy
A Randomized Controlled Trial of an Early Oral Nutritional Supplements Intervention Versus a Conventional Nutritional Intervention in Patients With Locally Advanced Nasopharyngeal Carcinoma Undergoing Concurrent Chemoradiotherapy
NCT04810936CI-TRIAL-00050826unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 carcinoma undergoing chemoradiotherapy will improve nutritional status, quality of life and treatment tolerance.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malnutrition | — | UNRESOLVED | — |
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oral nutritional supplements | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Early ONS intervention group
- description
- Patients in early ONS intervention group will receive nutritional counseling (follow-up visits once a week during radiotherapy and at the 1st and 3rd months after radiotherapy) and ONS intervention in the beginning of radiotherapy. The ONS is prescribed to increase oral intake of patients and to ensure total energy supply is more than 30 kcal/kg/day and protein intake more than 1.2 g/kg/day.
- interventionNames
- Dietary Supplement: oral nutritional supplements
- type
- NO_INTERVENTION
- label
- Standard nutrition intervention group
- description
- Patients in standard nutrition intervention group will receive nutritional counseling (follow-up visits once a week during radiotherapy and at the 1st and 3rd months after radiotherapy).
Primary outcomes (1)
- measure
- The percentage of patients who lose >5% of initial body weight
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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 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 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 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.
References
Publications (0)
Data not yet available
No reference posted for this study.