Clinical trial NCT05834712: 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
Overall status: COMPLETED
Phase: NA
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma
mobile platform
nutritional intervention
radiotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: weight loss
timeFrame: 1 month after chemoradiotherapy
Secondary outcomes:
measure: weight loss >10%
timeFrame: at the end of chemoradiotherapy
measure: weight loss >20%
timeFrame: at the end of chemoradiotherapy
measure: ncidence rate of adverse events (AEs)
timeFrame: at the end of chemoradiotherapy
measure: change of PG-SGA
timeFrame: 1 month after chemoradiotherapy
measure: change of NRS2002
timeFrame: 1 month after chemoradiotherapy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References: