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Completed

NCT Number: NCT05834712

Patients With Stage III-IVa Nasopharyngeal Carcinoma With or Without a 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mobile platform or not mobile platform

Device

Intervention using WeChat

Primary outcomes

  1. weight loss

    Time frame: 1 month after chemoradiotherapy

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

Secondary outcomes

  1. weight loss >10%

    Time frame: at the end of chemoradiotherapy

    Differences in the proportion of patients who lost >10% of their body weight at the end of chemoradiotherapy between experimental and control groups

  2. weight loss >20%

    Time frame: at the end of chemoradiotherapy

    Differences in the proportion of patients who lost >20% of their body weight at the end of chemoradiotherapy between experimental and control groups

  3. ncidence rate of adverse events (AEs)

    Time frame: at the end of chemoradiotherapy

    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.

  4. change of PG-SGA

    Time frame: 1 month after chemoradiotherapy

    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.

  5. change of NRS2002

    Time frame: 1 month after chemoradiotherapy

    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.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Apr 28, 2023
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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