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Trial Title:
Patients With Stage III-IVa Nasopharyngeal Carcinoma With or Without a Mobile Medical Platform Full-course Nutritional Intervention
NCT ID:
NCT05834712
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Conditions: Keywords:
Nasopharyngeal Carcinoma
mobile platform
nutritional intervention
radiotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
mobile platform or not mobile platform
Description:
Intervention using WeChat
Arm group label:
Mobile Platform Intervention Group
Arm group label:
Non-mobile Platform Intervention Group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Haiqiang Mai, MD,Ph.D
Phone:
86-20-8734-3643
Email:
maihq@mail.sysu.edu.cn
Contact backup:
Last name:
Qiuyan Chen, MD,Ph.D
Phone:
86-20-8734-3380
Email:
chenqy@mail.sysu.edu.cn
Investigator:
Last name:
Haiqiang Mai, MD,Ph.D
Email:
Principal Investigator
Investigator:
Last name:
Qiuyan Chen, MD,Ph.D
Email:
Principal Investigator
Investigator:
Last name:
Shanshan Guo, MD,Ph.D
Email:
Sub-Investigator
Start date:
May 11, 2022
Completion date:
December 2023
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05834712
