Patients with Stage III-IVa Nasopharyngeal Carcinoma with or Without a Mobile Medical Platform Full-course Nutritional Intervention

A Randomized, Controlled, Phase II Clinical Study on the Improvement of Malnutrition in Patients with Stage III-IVa Nasopharyngeal Carcinoma with or Without the Use of Mobile Medical Platform Full-course Nutritional Intervention

To study the difference in the proportion of patients with nasopharyngeal carcinoma who lost more than 10% of their body weight within 1 month after radiotherapy and chemotherapy using the mobile platform for whole-process individualized nutritional rehabilitation management compared with conventional nutritional rehabilitation management.

Study Overview

• Status: Completed
• Conditions: Nasopharyngeal Carcinoma
• Intervention / Treatment: Device: mobile platform or not mobile platform

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1.Voluntarily participate and sign the informed consent in writing.
• 2.Stage III-IVa (AJCC 8th edition staging) .
• 3.Received induction chemotherapy + concurrent chemoradiotherapy .
• 4.18-70 years old.
• 5.Pathologically diagnosed with non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, that is, WHO type II or III).
• 6.No previous anti-tumor therapy .
• 7.ECOG score 0-1.
• 8.Ensure contraception during the study period.
• 9.Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109/L, platelet (PLT) ≥100×109/L.
• 10. Liver function: ALT, AST < 2.5 times the upper limit of normal (ULN), total bilirubin < 2.0 × ULN.
• 11. Renal function: serum creatinine <1.5×ULN.
• 12.Able and willing to use a mobile phone or tablet to fill in the electronic scale.

Exclusion Criteria:

• 1.Received antitumor therapy in the past.
• 2. The pathology was keratinizing squamous cell carcinoma (WHO type I).
• 3.Pregnant women who are in the reproductive period and have not taken effective contraceptive measures.
• 4. Has suffered from other malignant tumors (except for cured basal cell carcinoma or carcinoma in situ of the cervix).
• 5.Patients with significantly low heart, liver, lung, kidney and bone marrow functions.
• 6.Serious, uncontrolled medical diseases and infections.
• 7.Concurrent use of other experimental drugs or other clinical trials.
• 8. Refused or unable to sign the informed consent to participate in the trial.
• 9.Those who have other contraindications to treatment.
• 10.Persons with personality or mental disorders, no capacity for civil conduct or limited capacity for civil conduct.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile Platform Intervention Group; The mobile platform is used to evaluate the nutrition of patients 2 weeks after the first course of induction chemotherapy, before radiotherapy, during radiotherapy, after radiotherapy, and 1 month after radiotherapy. The doctor pushes individualized nutrition education, oral advice, medication advice, etc. .	Device: mobile platform or not mobile platform; Intervention using WeChat
Active Comparator: Non-mobile Platform Intervention Group; Nutritional assessment of patients was performed at 2 weeks after 1 course of induction chemotherapy, before radiotherapy, during radiotherapy, at the end of radiotherapy, and at 1 month after the end of radiotherapy.	Device: mobile platform or not mobile platform; Intervention using WeChat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight loss	Differences in the proportion of patients who lost >10% of their body weight at 1 month after chemoradiotherapy between experimental and control groups	1 month after chemoradiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight loss >10%	Differences in the proportion of patients who lost >10% of their body weight at the end of chemoradiotherapy between experimental and control groups	at the end of chemoradiotherapy
weight loss >20%	Differences in the proportion of patients who lost >20% of their body weight at the end of chemoradiotherapy between experimental and control groups	at the end of chemoradiotherapy
ncidence rate of adverse events (AEs)	Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events(acute toxicity) as assessed by CTCAE v5.0.Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.	at the end of chemoradiotherapy
change of PG-SGA	Scored Patient-Generated Subjective Global Assessment (PG-SGA).It consists of two parts: the patient's self-assessment part and the medical staff's assessment part. The specific contents include seven aspects, including body weight, food intake, symptoms, activity and physical function, the relationship between disease and nutritional needs, metabolic needs, and physical examination. The first 4 Each aspect is evaluated by the patient himself, and the last three aspects are evaluated by the medical staff. The overall evaluation includes qualitative evaluation and quantitative evaluation.	1 month after chemoradiotherapy
change of NRS2002	The outstanding advantage of NRS2002 is that it can predict the risk of malnutrition, and can proactively and dynamically judge the changes in the nutritional status of patients, which is convenient for timely feedback of the nutritional status of patients, and provides evidence for adjusting nutritional support programs. It is a better nutritional risk screening tool.	1 month after chemoradiotherapy

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2022
• Primary Completion (Actual): September 24, 2023
• Study Completion (Actual): September 24, 2024

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: radiotherapy; nutritional intervention; Nasopharyngeal Carcinoma; mobile platform
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Carcinoma
• Other Study ID Numbers: 2021-FXY-332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No