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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

mobile platform or not mobile platform

About this trial

This is an interventional prevention trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, mobile platform, nutritional intervention, radiotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mobile Platform Intervention Group

Non-mobile Platform Intervention Group

Arm 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. .

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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.

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.

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.

Full Information

NCT ID

NCT05834712

First Posted

April 18, 2022

Last Updated

April 17, 2023

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT05834712

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 11, 2022 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma, mobile platform, nutritional intervention, radiotherapy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mobile Platform Intervention Group

Arm Type

Experimental

Arm 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. .

Arm Title

Non-mobile Platform Intervention Group

Arm Type

Active Comparator

Arm 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.

Intervention Type

Device

Intervention Name(s)

mobile platform or not mobile platform

Intervention Description

Intervention using WeChat

Primary Outcome Measure Information:

Title

weight loss

Description

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 Outcome Measure Information:

Title

weight loss >10%

Description

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

Title

weight loss >20%

Description

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

Title

ncidence rate of adverse events (AEs)

Description

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

Title

change of PG-SGA

Description

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

Title

change of NRS2002

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Qiuyan Chen, PhD

Phone

86-20-8734-3380

Email

chenqy@sysucc.org.cn

Facility Information:

Facility Name

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

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact: