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Search / Trial NCT04810936

Early Nutritional Intervention in NPC Patients Undergoing Concurrent Chemoradiotherapy

Launched by GUANGDONG PROVINCIAL PEOPLE'S HOSPITAL · Mar 19, 2021

Trial Information

Current as of May 05, 2025

Unknown status

Keywords

Nasopharyngeal Carcinoma Malnutrition Early Nutritional Intervention Chemoradiotherapy

ClinConnect Summary

Concurrent chemoradiotherapy is the standard treatment for locally advanced nasopharyngeal carcinoma (NPC). During chemoradiotherapy, malnutrition is present in 44-88% patients which is associated with adverse clinical outcomes. Although patients receive conventional nutritional intervention recommended by The European Society for Clinical Nutrition and Metabolism guidelines, there are still 35% NPC patients suffering from malnutrition during chemoradiotherapy.

Recent studies have shown that early nutritional intervention before radiotherapy reduced the prevalence of malnutrition. However,...

Gender

ALL

Eligibility criteria

  • 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.

About Guangdong Provincial People's Hospital

Guangdong Provincial People's Hospital is a leading tertiary healthcare institution located in Guangdong Province, China, renowned for its comprehensive medical services and advanced research capabilities. As a prominent clinical trial sponsor, the hospital is dedicated to advancing medical science through innovative research and the rigorous evaluation of new therapies and interventions. With a multidisciplinary team of experienced clinicians and researchers, the institution prioritizes patient safety and ethical standards while fostering collaborations with academic and industry partners to enhance healthcare outcomes and contribute to the global medical community.

Locations

Guangzhou, Guangdong, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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