Standardized nutrition treatment to improve nutrition and outcomes in advanced nasopharyngeal cancer with malnutrition

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, phase III trial compares a standardized nutrition therapy program with conventional nutrition care in patients with locally advanced nasopharyngeal carcinoma and malnutrition. Participants are adults 18–65 with newly diagnosed WHO II/III NPC stage III–IVa who will receive cisplatin and intensity-modulated radiotherapy. The intervention arm receives protocolized, standardized nutritional support during treatment while the control arm receives usual nutrition management, with follow-up to measure nutritional status and clinical outcomes. Eligibility requires adequate organ function and performance status, and the trial is run at major cancer centers in China.

Why it matters

Who can join: the full rules

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;

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Chong Zhao, MD — Sun Yat-Sen University Cancer Center
• Study coordinator: Jingjing Miao, MD
• Email: miaojingjing90@163.com
• Phone: 86-13631355201

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Docetaxel and SX-682 in head and neck cancers and prostate cancer

  This trial tests a new drug SX-682 together with docetaxel in adults whose head and neck cancers or prostate cancer have returned or spread.

  Recruiting Phase 1/2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07667400

• Becotatug Vedotin for EGFR-positive relapsed, refractory, or metastatic pediatric solid tumors

  This trial will test Becotatug Vedotin, an EGFR-targeted antibody-drug conjugate, to see if it is safe and helps children aged 2–18 with EGFR-positive relapsed, refractory, or metastatic solid tumors.

  Recruiting Phase 1 Sun Yat-sen University · Guangzhou, Guangdong · NCT07584499

• Induction and maintenance with MRG003, Tislelizumab, and Capecitabine for locally recurrent nasopharyngeal cancer

  This study tests a treatment combo of MRG003 and a PD-1 blocker first, then continues with Capecitabine plus the PD-1 blocker to see if it helps patients with locally recurrent NPC.

  Recruiting Phase 2 Fujian Cancer Hospital · Fuzhou, Fujian · NCT07331428

• Lower-dose (40.2 Gy) versus standard-dose (49.2 Gy) radiotherapy to low‑risk areas for chemosensitive Stage II nasopharyngeal cancer

  This trial will try a lower radiotherapy dose (40.2 Gy) instead of the standard 49.2 Gy for people with stage II nasopharyngeal cancer who had a strong response to induction chemo and have undetectable EBV DNA.

  Recruiting at 15 sites Phase 3 Sun Yat-sen University · Hefei, Anhui and 14 other locations · NCT07328854

• Screening for early nasopharyngeal (nose) cancer

  This project tests whether blood and saliva markers can find nasopharyngeal cancer early in adults aged 35 to 60 who are at higher risk because of ethnicity or family history.

  Recruiting at 2 sites National University Hospital, Singapore · Singapore and 1 other locations · NCT07019870

• Proton versus photon radiation for nasopharyngeal cancer

  This trial will test whether proton radiation works at least as well as standard photon radiation for adults newly diagnosed with nasopharyngeal cancer that has not spread.

  Recruiting Phase 3 Shandong Cancer Hospital and Institute · Jinan · NCT07000643

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.