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OpenTrials
Completed

NCT Number: NCT03240835

The Function of PA, RBP and TRSF in Malnutrition Detecting and Nutritional Status Monitoring for NPC Patients

The purpose of this study is to study the function of pre-albumin, retinol conjugated protein and transferrin in early malnutrition detecting and nutritional status dynamic monitoring for local advanced nasopharyngeal carcinoma patients with chemoradiotherapy.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)
  • All genders,range from 18~60 years old
  • Karnofsky performance status(KPS) ≥ 80
  • Clinical stage III~IVb(UICC 8th)
  • Without significant digestive system disease,nutritional and metabolic diseases or endocrine disease
  • Without significant cardiac,respiratory,kidney or liver disease
  • Not received radiotherapy, chemotherapy and other anti-tumor treatment(including immunotherapy)
  • white blood cell(WBC) count ≥ 4×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, Hemoglobin(HGB) ≥ 10g/L, platelet(PLT) count ≥ 100×109/L
  • alanine aminotransferase (ALT) or aspartate aminotransferase(AST) < 1.5×upper limit of normal(ULN), bilirubin < 1.5×ULN, alanine aminotransferase (CCR) ≥ 30ml/min
  • Inform consent form

Exclusion criteria

  • Distance metastases
  • Second malignancy within 5 years
  • Drug or alcohol addition
  • Do not have full capacity for civil acts
  • Active systemic infections
  • Chronic consumptions
  • Mental disorder
  • Pregnancy or lactation
  • Concurrent immunotherapy or hormone therapy for other diseases
  • Severe complication, eg, uncontrolled hypertension

Treatment and study plan

cisplatin and docetaxel

Drug

NACt:cisplatin 75 mg/m2 intravenous infusion in day1,docetaxel 75 mg/m2 intravenous infusion in day1,both drugs are given every 3 weeks, two cycles.

CCRT: cisplatin (100mg/m2 on day 1) every three weeks for two cycles.

IMRT

Radiation

intensity modulation radiation therapy

Primary outcomes

  1. changes of PA/RBP/TRSF

    Time frame: baseline and during treatment

    to evaluate the changes of PA/RBP/TRSF during the treatment

Secondary outcomes

  1. Change of Body weight

    Time frame: baseline and during treatment

    to compare the change of weight loss during treatment

  2. Number of Participants With Abnormal Laboratory Values

    Time frame: baseline and during treatment

    To observe the complete blood cell count and blood biochemical examination during treatment

  3. Acute Toxicity

    Time frame: baseline and during treatment

    To evaluate the acute toxicity with Common Terminology Criteria For Adverse Events (CTCAE) 4.0

Sponsors and collaborators

Lead sponsor

Zhao Chong

Other

Collaborators

  • Wu Jieping Medical Foundation

Registry information

Official study title

The Function of Pre-Albumin, Retinol Conjugated Protein and Transferrin in Early Malnutrition Detecting and Nutritional Status Dynamic Monitoring for Local Advanced Nasopharyngeal Carcinoma Patients With Chemoradiotherapy

Important dates

Study start
2017
Primary completion
2018
Study completion
2025
First posted
Aug 7, 2017
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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