Effect of Oral Nutritional Supplements on Body Weight Loss of Patients With Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04823468
• Other study ID #: FYYY-FLK-202001
• Status: Recruiting
• Phase: N/A
• Start date: July 19, 2021
• Est. completion date: September 2025

Study information

• Verified date: March 2024
• Source: First Affiliated Hospital of Fujian Medical University
• Contact: Jinsheng Hong
• Phone: +8613799375732
• Email: 13799375732[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: September 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Carcinoma
• Nasopharyngeal Carcinoma
• Nutritional Support
• Weight Loss

Intervention

Dietary Supplement:
• Abbott®Ensure
Abbott®Ensure: 55.8 g each time, three times a day, from the beginning to the end of radiotherapy

Radiation:
• Intensity Modulated Radiation Therapy
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).

Drug:
• cisplatin
80-100 mg/m² cisplatin given intravenously every 3 weeks concurrently with radiotherapy.

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan
China	900th hospital of the joint logistics team, PLA	Fuzhou	Fujian
China	First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong
China	Jiangxi Provincial Cancer Hospital	Nanchang	Jiangxi
China	The Nanping First Affiliated Hospital of Fujian Medical University	Nanping	Fujian
China	Quanzhou First Hospital Affiliated to Fujian Medical University	Quanzhou	Fujian
China	The Second Affiliated Hospital of Fujian Medical University	Quanzhou	Fujian
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	Zhongshan Hospital Xiamen University	Xiamen	Fujian
China	Zhangzhou Affiliated Hospital of Fujian Medical University	Zhangzhou	Fujian

Sponsors (13)

Lead Sponsor

Collaborator

Jinsheng Hong

900th hospital of the joint logistics team, PLA, Fujian Cancer Hospital, Fujian Medical University Union Hospital, Hunan Cancer Hospital, Jiangxi Provincial Cancer Hospital, Nanfang Hospital, Southern Medical University, Quanzhou First Hospital Affiliated to Fujian Medical University, The First Affiliated Hospital of Xiamen University, The Nanping First Affiliated Hospital of Fujian Medical University, The Second Affiliated Hospital of Fujian Medical University, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhongshan Hospital Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From time of randomization to the date of radiotherapy ends, up to 7 weeks
Secondary	PG-SGA Score	The scores assessed by Patient-Generated Subjective Nutrition Assessment (PG-SGA) at baseline and weekly during the course of radiotherapy	From time of randomization to the date of radiotherapy ends, up to 7 weeks
Secondary	Incidence of participants with grade =3 oral mucositis	Incidence of grade 3-4 oral mucositis assessed by CTCAE v5.0, evaluated weekly during radiotherapy	During the course of radiotherapy, up to 7 weeks
Secondary	Days of radiotherapy interruption	The number of days that radiotherapy was interrupted due to treatment-related toxicity	During the course of radiotherapy, up to 7 weeks
Secondary	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.	From time of randomization to the date of radiotherapy ends, up to 7 weeks
Secondary	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.	During the course of chemoradiotherapy, up to 7 weeks
Secondary	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.	During the course of chemoradiotherapy, up to 7 weeks