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New treatment option for Nasopharyngeal Carcinoma
Official title Effect of Standard Nutrition Therapy on Nutritional Status and Prognosis in Locoregionally Advanced Nasopharyngeal Carcinoma Patients With Malnutrition
ClinicalTrials.gov ID: NCT04436965
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nasopharyngeal carcinoma.
Also referred to as DDP.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- Have some PEG/PEJ contraindications, such as coagulopathy, recent anticoagulant medications and aspirin, gastric ulcer or history of gastric...
- 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;
See the full eligibility 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;
- 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...
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.