Clinical trial NCT04823468: Effect of Oral Nutritional Supplements on Body Weight Loss of Patients With Nasopharyngeal Carcinoma
Official title: Effect of Oral Nutritional Supplements From the Beginning of Radiotherapy on Body Weight Loss of Patients With Nasopharyngeal Carcinoma and Its Cost-Utility Analysis: A Prospective Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasopharyngeal Carcinoma
Nutritional Support
Keywords: Nasopharyngeal Carcinoma
Nutritional Support
Chemoradiotherapy
Dietary Supplements
Body Weight
Cost-Effectiveness Analysis
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
Collaborators: name: Fujian Cancer Hospital
name: The Second Affiliated Hospital of Fujian Medical University
name: The Nanping First Affiliated Hospital of Fujian Medical University
name: Quanzhou First Hospital
name: Fujian Medical University Union Hospital
name: Zhangzhou Affiliated Hospital of Fujian Medical University
name: Hunan Cancer Hospital
name: Jiangxi Provincial Cancer Hospital
name: 900 Hospital of Joint Logistics Support Force of PLA
name: Nanfang Hospital, Southern Medical University
name: The First Affiliated Hospital of Xiamen University
name: Zhongshan Hospital Xiamen University
First posted: 2021-03-30
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Newly histologic diagnosis of nasopharyngeal carcinoma;
* All genders, range from 18-70 years old;
* Clinical stage II-IVa according to the 8th edition of the Union for International Cancer Control/American Joint Committee on Cancer (UICC/AJCC) staging system;
* Patient-Generated Subjective Nutrition Assessment (PG-SGA) score ≤8;
* Main organ functions test should be satisfied the following conditions: (1) Absolute neutrophil count (ANC) ≥1.5×10\^9/L; (2) Platelet (PLT) ≥80×10\^9/L; (3) Hemoglobin (Hb) ≥90 g/L; (4) Bilirubin \< 1.5 times the upper limit of normal value (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 times the upper limit of normal value; (5) Creatinine \< 1.5 times the upper limit of normal value or creatinine clearance rate \>60 ml/min.

Exclusion Criteria:

* Patients whose energy intake is less than 60% of the target energy requirement for 3 days or more;
* Have or are suffering from other malignant tumors;
* Refuse concurrent chemoradiotherapy;
* With diabetics, galactosemia, or sever metabolic diseases or endocrine diseases;
* Cannot take oral or enteral nutrition, including intestinal obstruction, severe short bowel syndrome or high output fistula, or with severe digestive system diseases;
* Known allergic reaction to any component of Abbott®Ensure, or severe allergic constitution;
* Pregnant or lactating women;
* With previous or ongoing clinical trials;
* Refuse to sign inform consent form.

Primary outcomes:
measure: Incidence of weight loss > 5%
timeFrame: From time of randomization to the date of radiotherapy ends, up to 7 weeks
Secondary outcomes:
measure: PG-SGA Score
timeFrame: From time of randomization to the date of radiotherapy ends, up to 7 weeks
measure: Incidence of participants with grade ≥3 oral mucositis
timeFrame: During the course of radiotherapy, up to 7 weeks
measure: Days of radiotherapy interruption
timeFrame: During the course of radiotherapy, up to 7 weeks
measure: Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 v3.0 (EORTC QLQ-C30 v3.0)
timeFrame: From time of randomization to the date of radiotherapy ends, up to 7 weeks
measure: Increment Cost-Utility Ratio (ICUR）
timeFrame: During the course of chemoradiotherapy, up to 7 weeks
measure: Score of EQ-5D-5L questionnaire
timeFrame: During the course of chemoradiotherapy, up to 7 weeks
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Fuzhou
country: China
facility: First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Fuzhou
country: China
facility: 900th hospital of the joint logistics team, PLA
state: Fujian
city: Nanping
country: China
facility: The Nanping First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Quanzhou
country: China
facility: Quanzhou First Hospital Affiliated to Fujian Medical University
state: Fujian
city: Quanzhou
country: China
facility: The Second Affiliated Hospital of Fujian Medical University
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
state: Fujian
city: Zhangzhou
country: China
facility: Zhangzhou Affiliated Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanchang
country: China
facility: Jiangxi Provincial Cancer Hospital
state: Jiangxi
Study officials:
affiliation: First Affiliated Hospital of Fujian Medical University
name: Jinsheng Hong
role: PRINCIPAL_INVESTIGATOR
References: