Early Nutritional Intervention in NPC Patients Undergoing Concurrent Chemoradiotherapy

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/A

Clinical Study ID

NCT04810936
GDREC2018296H(R1)
  • Ages 18-74
  • All Genders

Study 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 carcinoma undergoing chemoradiotherapy will improve nutritional status, quality of life and treatment tolerance.

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

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, there are few randomized controlled clinical studies comparing early oral nutritional supplements (ONS) intervention to conventional nutritional intervention in NPC patients undergoing chemoradiotherapy.

This single center, open-label, randomized controlled clinical trial was designed to investigate whether early ONS intervention compared to conventional nutritional intervention improves nutritional status, treatment tolerance and quality of life, and decreases the incidence of grade 3-4 treatment related side-effects in NPC patients undergoing chemoradiotherapy.

Connect with a study center

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong 510080
    China

    Active - Recruiting

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