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Randomized controlled trial on the effectiveness,security and superiority of Individualized enteral nutrition for the head and neck cancer patients undergoing concurrent chemoradiotherapy

Randomized controlled trial on the effectiveness,security and superiority of Individualized enteral nutrition for the head and neck cancer patients undergoing concurrent chemoradiotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016070
Enrollment
Unknown
Registered
2018-05-09
Start date
2019-01-01
Completion date
Unknown
Last updated
2018-05-14

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

Conditions

Tumor malnutrition

Interventions

test group:Individually formulated enteral nutrition solution
Control group:Standardized enteral nutrition solution

Sponsors

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Mediccal School
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Subjects diagnosed with malignant tumors by clinical symptoms, imaging examinations, and pathological examinations before surgery; 2.For patients undergoing concurrent chemoradiotherapy, toxic side effects assessment requires a liquid diet or a field test to evaluate subjects who need tube feeding nutrition; 3.Absolute neutrophil counts (fractional nucleus and ribbon nucleus) =1.5×109/L, platelets =100×10^9/L, hemoglobin =9 g/dL; 4.After nutrition risk screening (NRS2002), NRS2002 =3 points; 5.After the nutritional status assessment(PG-SGA)PG-SGA=2 points; 6.Life expectancy> 3 months; 7.Bilirubin, alkaline phosphatase, aspartate aminotransferase, and alanine aminotransferase = 1.5 times the normal upper limit (ULN); 8.Aged 18-75 , all genders; 9.Subjects are conscious, have no communication problems and can answer the question; 10.Agree to participate in this clinical trial and voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1.Head or neck surgery or previous head and neck radiotherapy; 2.Patients with distant tumor metastases; 3.Subjects had or had previous history of other cancers; 4.Subjects with active bacterial, viral or fungal infections (>= Level 2 of NCI-CTC, 3rd Edition); 5.Severe malnutrition, albumin <30g/L; 6.Gastrointestinal tract accompanied by diseases with abnormal digestion and absorption; 7.Use other specially formulated foods or medicines; 8.Thyroid dysfunction; 9.There are serious heart, lung and brain diseases, etc. 10.There are difficult to control diabetes, or other metabolic diseases; 11.With chronic hepatitis, cirrhosis, chronic nephritis, renal insufficiency, etc. 12.Subjects with contraindications to enteral nutrition; 13.Subjects with allergic or intolerable enteral nutrition; 14.Alcoholism or drug addiction; 15.Pregnancy or breastfeeding, or women of childbearing age refuse to use contraception; 16.Researchers consider it inappropriate to participate in this experiment.

Design outcomes

Primary

MeasureTime frame
Albumin;RTOG scale;????CD3+, CD4+, CD8+;

Secondary

MeasureTime frame
Body weight;QLICP-HN (V1.0) scale;Medical expenses;

Countries

China

Contacts

Public ContactYan Jing

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Mediccal School

yj20030610@126.com+86 15805182426

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026