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

Sun Yat-sen University

Status: Completed

Conditions: Nasopharyngeal Carcinoma

Treatments: Device: mobile platform or not mobile platform

Study type: Interventional

Funder types: Other

Identifiers

NCT05834712

2021-FXY-332

Details and patient eligibility

About

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.

Enrollment: 224 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

Mobile Platform Intervention Group

Experimental group

Description:

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. .

Treatment:

Device: mobile platform or not mobile platform

Non-mobile Platform Intervention Group

Active Comparator group

Description:

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.

Treatment:

Device: mobile platform or not mobile platform