Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Location status: Recruiting
NCT Number: NCT04436965
This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy of standard nutrition treatment versus conventional nutrition treatment in local advanced nasopharyngeal carcinoma patients.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 3
Guangzhou, Guangdong, 510060, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standardized nutrition therapy with ONS, nasal feeding tube, PEG or parenteral nutrition
Patients in both arms received concurrent cisplatin chemotherapy:100 mg/m² cisplatin given intravenously every 3 weeks on days 1, 22 concurrently with radiotherapy.
Other names: DDP
Patients in both arms received Intensity Modulated Radiation Therapy:All target volumes were outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes were defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose was 70-72 Gy to PTVnx (Planning target volume of the primary tumor), 64-70 Gy to PTVnd (Planning target volume of the cervical lymph node),60- 64Gy to PTV1 (Planning target volume 1), and 54-58 Gy to PTV2 (Planning target volume 2) in 30-32 fractions. The details of dose limits for organs at risk were based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).
Other names: IMRT
Time frame: 2 months
To observe the changes and differences in the incidence of the actual weight/ideal weight (IBW%) less than 90% during the treatment of the two groups of patients
Time frame: 36 months
To observe the changes and differences in the incidence of body weight loss (WL)≥5%/10%, actual body weight/usual body weight (UBW%), body mass index (BMI) before, during and after treatment
Time frame: 36 months
To observe patients' complete blood cell count and blood biochemical examination during the treatment and three years after the treatment.
Time frame: 36 months
From date of recruited to death
Time frame: 36 months
From date of recruited to disease progression
Time frame: 36 months
From date of recruited to locoregional recurrence
Time frame: 36 months
From date of recruited to distant metastasis
Time frame: 36 months
To observe the changes and differences of nutrition screening and evaluation (NRS2002 and PG-SGA) before, during and after treatment in the two groups
Time frame: 36 months
Evaluating with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L)
Time frame: through study completion, an average of 2 months
Evaluating with CTCAE v5.0
Time frame: 36 months
assessed with Radiation Therapy Oncology Group radiation morbidity scoring criteria
Contact information is provided by the study sponsor or research team.
Sun Yat-sen University
Other
Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition: A Prospective, Multicenter, Phase III Randomized Control Clinical Trial
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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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