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

Nasopharyngeal Carcinoma Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05834712
• Other study ID #: 2021-FXY-332
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2022
• Est. completion date: December 2023

Study information

• Verified date: April 2023
• Source: Sun Yat-sen University
• Contact: Qiuyan Chen, PhD
• Phone: 86-20-8734-3380
• Email: chenqy[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Device:
• mobile platform or not mobile platform
Intervention using WeChat

Locations

Country	Name	City	State
China	Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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