An interventional study of Abbott®Ensure and Intensity Modulated Radiation Therapy in Nasopharyngeal Carcinoma and Nutritional Support, sponsored by Jinsheng Hong. Completed at 13 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-06-10.
Sponsored by Jinsheng Hong · Not applicable, Interventional, and Treatment
Concurrent chemoradiotherapy(CCRT) is the principal treatment for nasopharyngeal carcinoma(NPC). Studies have shown that malnutrition is very common in patients with NPC after chemoradiotherapy. Malnutrition can lead to weight loss, treatment interruption, prolonged stay in hospital, increased treatment costs, reduced tolerance to anti-tumor therapy, reduced quality of life and shortened survival time. Nutritional intervention can improve the nutritional status, reduce treatment-related toxicity and improve the survival of patients with NPC.
The first choice of nutritional intervention is oral nutritional supplements(ONS). Some retrospective studies with small samples have found that early nutritional intervention can reduce weight loss and severe oral mucositis in patients with NPC, compared with late nutritional intervention. Therefore, the investigators proposed the hypothesis that ONS from the beginning of radiotherapy can reduce the nutritional impairment, treatment-related toxicity and treatment costs of patients with NPC, and improve their quality of life. The aim of this multicenter randomized controlled clinical trial is to evaluate the efficacy and cost utility of ONS from the beginning to the end of radiotherapy.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 236 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
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Exclusion Criteria:
In addition to conventional dietary instruction and individualized nutritional counselling, patients were given additional ONS (Abbott®Ensure of 55.8 g tid) from the beginning to the end of radiotherapy.
Dietary Supplement: Abbott®Ensure · Radiation: Intensity Modulated Radiation Therapy · Drug: cisplatin
Conventional dietary instruction and individualized nutritional counselling from the beginning to the end of radiotherapy.
Radiation: Intensity Modulated Radiation Therapy · Drug: cisplatin
Abbott®Ensure: 55.8 g each time, three times a day, from the beginning to the end of radiotherapy
The prescribed dose was 68-76 Gy to Planning target volume of the primary tumor (PTVnx), 66-70 Gy to Planning target volume of the cervical lymph node (PTVnd), 60-64 Gy to planning target volume 1 (PTV1), and 50-54 Gy to planning target volume 2 (PTV2) in 30-33 fractions. The details of dose limits for organs at risk were based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).
80-100 mg/m² cisplatin given intravenously every 3 weeks concurrently with radiotherapy.
Incidence of weight loss > 5%
The percentage of patients whose body weight decreased more than 5% over baseline, body weight (in kilograms) are measured at baseline and weekly during the course of radiotherapy
Time frame: From time of randomization to the date of radiotherapy ends, up to 7 weeks
PG-SGA Score
The scores assessed by Patient-Generated Subjective Nutrition Assessment (PG-SGA) at baseline and weekly during the course of radiotherapy
Time frame: From time of randomization to the date of radiotherapy ends, up to 7 weeks
Incidence of participants with grade ≥3 oral mucositis
Incidence of grade 3-4 oral mucositis assessed by CTCAE v5.0, evaluated weekly during radiotherapy
Time frame: During the course of radiotherapy, up to 7 weeks
Days of radiotherapy interruption
The number of days that radiotherapy was interrupted due to treatment-related toxicity
Time frame: During the course of radiotherapy, up to 7 weeks
Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 v3.0 (EORTC QLQ-C30 v3.0)
The standard scores assessed by the EORTC QLQ-C30 v3.0 at baseline and the end of radiotherapy.
Time frame: From time of randomization to the date of radiotherapy ends, up to 7 weeks
Increment Cost-Utility Ratio (ICUR）
The Increment cost-utility ratio is used to assess the economics of ONS, which is calculated as incremental cost divided by incremental utility.
Time frame: During the course of chemoradiotherapy, up to 7 weeks
Score of EQ-5D-5L questionnaire
The standard scores assessed by the EuroQol- 5 dimension-5 level (EQ-5D-5L ) questionnaire. Collect this questionnaire only in the responsible center.
Time frame: During the course of chemoradiotherapy, up to 7 weeks
Plan to share: No
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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