NCT04436965 Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition
| NCT ID | NCT04436965 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Yat-sen University |
| Condition | Nasopharyngeal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 266 participants |
| Start Date | 2021-08-16 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 266 participants in total. It began in 2021-08-16 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy of standard nutrition treatment versus conventional nutrition treatment in local advanced nasopharyngeal carcinoma patients.
Eligibility Criteria
Inclusion Criteria: * Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III); * All genders，range from 18～65 years old; * Karnofsky performance status(KPS) ≥ 80; * Clinical stage III\~IVa(AJCC/UICC 8th); * Without significant digestive system disease，nutritional and metabolic diseases or endocrine disease * Without significant cardiac，respiratory，kidney or liver disease; * Not received radiotherapy, chemotherapy and other anti-tumor treatment(including immunotherapy); * White blood cell(WBC) count ≥ 4×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, Hemoglobin(HGB) ≥ 9g/L, platelet(PLT) count ≥ 100×109/L * Total bilirubin(TBIL)、alanine aminotransferase (ALT) or aspartate aminotransferase(AST) \< 2.5×upper limit of normal(ULN); * Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula); * No contraindications to chemotherapy or radiotherapy; * Inform consent form; Exclusion Criteria: * Have some PEG/PEJ contraindications, such as coagulopathy, recent anticoagulant medications and aspirin, gastric ulcer or history of gastric bleeding, portal hypertension combined with abdominal and esophageal fundal varices, pyloric obstruction due to residual stomach under the costal arch after various major gastrectomy or various reasons; * Distance metastases; * Have or are suffering from other malignant tumors; * Participating in other clinical trials; * Drug or alcohol addition; * Do not have full capacity for civil acts; * Mental disorder; * Pregnancy or lactation; * Severe complication, eg, uncontrolled hypertension;
Contact & Investigator
Chong Zhao, MD
PRINCIPAL INVESTIGATOR
Sun Yat-Sen University Cancer Center
Frequently Asked Questions
Who can join the NCT04436965 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Nasopharyngeal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04436965 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 266 participants.
Is NCT04436965 currently recruiting?
Yes, NCT04436965 is actively recruiting participants. Contact the research team at miaojingjing90@163.com for enrollment information.
Where is the NCT04436965 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT04436965 clinical trial?
NCT04436965 is sponsored by Sun Yat-sen University. The principal investigator is Chong Zhao, MD at Sun Yat-Sen University Cancer Center. The trial plans to enroll 266 participants.