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

NCT05834712 | Completed

• 1 other identifier: 2021-FXY-332
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma; mobile platform; nutritional intervention; radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• weight loss >10%

  at the end of chemoradiotherapy

• weight loss >20%

  at the end of chemoradiotherapy

• ncidence rate of adverse events (AEs)

  at the end of chemoradiotherapy

• change of PG-SGA

  1 month after chemoradiotherapy

• change of NRS2002

  1 month after chemoradiotherapy

Study Arms (2)

Mobile Platform Intervention Group

EXPERIMENTAL

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

Non-mobile Platform Intervention Group

ACTIVE COMPARATOR

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

Interventions

mobile platform or not mobile platform DEVICE

Intervention using WeChat

Mobile Platform Intervention Group; Non-mobile Platform Intervention Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 28, 2023
• Study Start: May 11, 2022
• Primary Completion: September 24, 2023
• Study Completion: September 24, 2024
• Last Updated: January 27, 2025

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)