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

January 29, 2023 updated by: Zhao Chong

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Cancer Center, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

III-IVb(Union for International Cancer Control,UICC 8th) NPC patients with histologic diagnosis of World Health Organization(WHO) II/III

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CCRT±NACT
Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin) , or treated with CCRT only
Drug: cisplatin and docetaxel

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.

Radiation: IMRT
intensity modulation radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes of PA/RBP/TRSF
Time Frame: baseline and during treatment
to evaluate the changes of PA/RBP/TRSF during the treatment
baseline and during treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Body weight
Time Frame: baseline and during treatment
to compare the change of weight loss during treatment
baseline and during treatment
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
baseline and during treatment
Acute Toxicity
Time Frame: baseline and during treatment
To evaluate the acute toxicity with Common Terminology Criteria For Adverse Events (CTCAE) 4.0
baseline and during treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhao Chong

Collaborators

Wu Jieping Medical Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 12, 2017

Primary Completion (ACTUAL)

December 31, 2018

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

July 27, 2017

First Submitted That Met QC Criteria

August 1, 2017

First Posted (ACTUAL)

August 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 29, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC-PA/RBP/TRSF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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