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CompletedNCT05834712Updated Jan 27, 2025

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

An interventional study of mobile platform or not mobile platform in Nasopharyngeal Carcinoma, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-01-27.

Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
224
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Nasopharyngeal Carcinoma

Keywords

  • Nasopharyngeal Carcinoma
  • mobile platform
  • nutritional intervention
  • radiotherapy
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 224 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.
    1. Liver function: ALT, AST \< 2.5 times the upper limit of normal (ULN), total bilirubin \< 2.0 × ULN.
    1. 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

Exclusion Criteria:

  • 1.Received antitumor therapy in the past.
    1. 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.
    1. 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.
    1. 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
224 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Devicemobile platform or not mobile platform

    Intervention using WeChat

06

What researchers measure

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

    Time frame: 1 month after chemoradiotherapy

Secondary outcomes

  1. 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

    Time frame: at the end of chemoradiotherapy

  2. 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

    Time frame: at the end of chemoradiotherapy

  3. 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.

    Time frame: at the end of chemoradiotherapy

  4. 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.

    Time frame: 1 month after chemoradiotherapy

  5. 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.

    Time frame: 1 month after chemoradiotherapy

07

Study locations

1 site
  • Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510060, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05834712
Lead sponsor
Sun Yat-sen University
Responsible party
Hai-Qiang Mai,MD,PhD (professor, Sun Yat-sen University) — Principal investigator
First posted
Apr 28, 2023
Start date
May 11, 2022
Primary completion
Sep 24, 2023
Completion
Sep 24, 2024
Last update
Jan 27, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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