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Effects of Ready-to-Drink liquid diet vs standard polymeric formula on nutritional status in patients with head and neck cancer requiring tube feeding: a non-inferiority randomized controlled trial.

Effects of Ready-to-Drink liquid diet vs standard polymeric formula on nutritional status in patients with head and neck cancer requiring tube feeding: a non-inferiority randomized controlled trial.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250718003
Enrollment
30
Registered
2025-07-18
Start date
2024-04-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck cancer patients Enteral nutrition, head and neck cancer, nutritional support, nutritional status, randomized con-trolled trial, tube feeding

Interventions

Sponsors

Prince of Songkla University
Lead Sponsor
Faculty of Medicine, Prince of Songkla University
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older 2. Willing to cooperate with treatment and able to provide reliable information 3. Diagnosed with head and neck cancer, completed standard treatment, and currently receiving enteral nutrition via NG feeding or PEG 4. Not currently participating in any other medical nutrition research studies 5. Glomerular filtration rate greater than 30 6. Not classified as significant risk for refeeding syndrome according to NICE guideline, defined as follows 6.1 Body mass index less than 16 kilograms per square meter 6.2 Unintentional weight loss greater than 7 point 5 percent in 3 months or greater than 10 percent in 6 months 6.3 No food intake for 7 days or intake less than 50 percent of requirement for 5 days during acute illness or less than 50 percent for 1 month without illness 6.4 Evident loss of subcutaneous fat or muscle mass 6.5 High risk due to existing comorbidities 7. Laboratory results for refeeding syndrome monitoring are within normal limits 8. No history of neuropathy or stroke and able to perform hand grip strength test

Exclusion criteria

Exclusion criteria: 1. Volunteers with allergies to any ingredients in the study products 1.1 PSU Blen: chicken, mung beans, rice bran oil, soybeans, maltodextrin 1.2 Blendera: sugar, MCT oil, rice bran oil, soybeans, maltodextrin 2. Patients with diabetes due to the presence of sugar in Blendera 3. Patients diagnosed with gastrointestinal obstruction, gastrointestinal dysmotility, or diarrhea more than 3 times per day 4. Patients with liver disease classified as Class C by Child Pugh Classification 5. Patients with impaired kidney function (serum creatinine greater than 2 mg per dL) 6. Pregnant or breastfeeding patients

Design outcomes

Primary

MeasureTime frame
SGA 1 month PG-SGA

Secondary

MeasureTime frame
hand grip strength 1 month hand grip strength,Body weight 1 month Body weight,BMI 1 month BMI,Serum albumin 1 month Serum albumin,Hemoglobin level 1 month Hemoglobin level,Platelet count 1 month Platelet count

Countries

Thailand

Contacts

Public ContactManupol Tangthongkum

Faculty of Medicine, Prince of Songkla University

tmanupol@gmail.com0873913877

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026