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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03240835
Recruitment Status : Active, not recruiting
First Posted : August 7, 2017
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
Wu Jieping Medical Foundation
Information provided by (Responsible Party):
Zhao Chong, Sun Yat-sen University

Brief Summary:
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.

Condition or disease Intervention/treatment
Nasopharyngeal Carcinoma Malnutrition Drug: cisplatin and docetaxel Radiation: IMRT

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official 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
Actual Study Start Date : September 12, 2017
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

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




Primary Outcome Measures :
  1. changes of PA/RBP/TRSF [ Time Frame: baseline and during treatment ]
    to evaluate the changes of PA/RBP/TRSF during the treatment


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240835


Locations
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China, Guangdong
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Zhao Chong
Wu Jieping Medical Foundation

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Responsible Party: Zhao Chong, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03240835     History of Changes
Other Study ID Numbers: NPC-PA/RBP/TRSF
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhao Chong, Sun Yat-sen University:
pre-Albumin
Retinol Conjugated Protein
Transferrin
Locoregionally Advanced Nasopharyngeal Carcinoma
nutrition
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Malnutrition
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nutrition Disorders
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action