Effect of Chemoradiotherapy on Nutritional Status in Advanced NPC Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

186 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2020-06-30

Brief Summary

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This is an prospective，open-label, none-interventional, observational， multicenter phase II clinical trial. The purpose of this study is to observe the effect of neoadjuvant chemotherapy followed by concurrent chemoradiation therapy(CCRT) on nutritional status in locoregionally advanced nasopharyngeal carcinoma(NPC) patients, analyse the changes of patients' nutrition status during the treatment and the connection between nutrition changes and curative effects, evaluate nutritional risks under the neoadjuvant chemotherapy and CCRT and provide data and basis for further study。

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Detailed Description

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Conditions

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Nasopharyngeal Carcinoma Malnutrition

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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NC+CCRT

Patients treated with neoadjuvant chemotherapy(NC) (cisplatin and docetaxel) and CCRT (cisplatin)

cisplatin and docetaxel

Intervention Type DRUG

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

CCRT: intensity modulation radiation therapy(IMRT) and cisplatin (100mg/m2 on day 1) every three weeks for three\\three cycles during radiation therapy(RT).

Dietary supplement: enteral nutrition and parenteral nutrition

Interventions

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cisplatin and docetaxel

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

CCRT: intensity modulation radiation therapy(IMRT) and cisplatin (100mg/m2 on day 1) every three weeks for three\\three cycles during radiation therapy(RT).

Dietary supplement: enteral nutrition and parenteral nutrition

Intervention Type DRUG

Other Intervention Names

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radiation enteral nutrition and parenteral nutrition

Eligibility Criteria

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Inclusion Criteria

* Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II)
* All genders，range from 18～65 years old
* Karnofsky performance status(KPS) ≥ 80
* Clinical stage III\~IVb(UICC 7th)
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No