In children with cancer and undernutrition, to see if feeding by tube is better than feeding by mouth

Nasogastric Tube feeding versus Oral feeding for treatment of Moderate to Severe Acute undernutrition in children with cancer: A randomized, open-label, parallel-group, phase III trial. - NORMS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061179

Enrollment

240

Registered

2024-01-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Nasogastric tube feeding: In the intervention arm, we will be inserting a nasogastric tube in moderate to severely malnourished children with cancer. This is a routinely practiced inter

Eligibility

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed children with cancer aged 1-18 years at the time of enrolment. 2. Planned for treatment of cancer with chemotherapy. 3. Undernutrition defined according to the World Health Organization (WHO) criteria: For children less than 2 years: Weight/Length (W/L), 2-5 years: Weight/Height (W/H) and 5-18 years: BMI Z Score: less than -2 Standard Deviations (SD) to -3 SD (moderate acute undernutrition) or BMI Z score less than - 3 SD (severe undernutrition) or Mid Upper Arm Circumference (MUAC) less than/equal to 25th percentile whichever is lower.

Exclusion criteria

Exclusion criteria: 1. Any contraindication for nasogastric tube feeding (non-functioning GI, uncontrolled GI side effects and inability to place a nasogastric tube). 2. Children judged to be too ill to participate at the discretion of the attending physician. 3. Children with diagnosis of brain tumor or nasopharyngeal carcinoma. 4. Parents refuse to give consent or children above 7 years of age refuse to give assent to participate in the study.

Design outcomes

Primary

Measure	Time frame
To evaluate proportion of patients with weight gain >5% at 6 weeks in both groups, in children with cancer and moderate or severe undernutritionTimepoint: 0 to 6 weeks	—

Secondary

Measure	Time frame
To compare various treatment related toxicities in the two groupsTimepoint: 0 to 6 weeks;To evaluate EFS and OS in each groupTimepoint: 0 to 6 weeks;To evaluate proportion of patients with gain of Body Mass Index (BMI) by 5%, Mid-Upper Arm circumference (MUAC) and Triceps Skin Fold Thickness (TSFT) by 10% in both groups Timepoint: 0 to 6 weeks;To evaluate the pediatric quality of life in each groupTimepoint: 0 to 6 weeks;To evaluate the proportion of patients who do not complete at least 4 weeks of interventionTimepoint: 0 to 6 weeks	—

Measure

Time frame

To compare various treatment related toxicities in the two groupsTimepoint: 0 to 6 weeks;To evaluate EFS and OS in each groupTimepoint: 0 to 6 weeks;To evaluate proportion of patients with gain of Body Mass Index (BMI) by 5%, Mid-Upper Arm circumference (MUAC) and Triceps Skin Fold Thickness (TSFT) by 10% in both groups Timepoint: 0 to 6 weeks;To evaluate the pediatric quality of life in each groupTimepoint: 0 to 6 weeks;To evaluate the proportion of patients who do not complete at least 4 weeks of interventionTimepoint: 0 to 6 weeks

—

Countries

India

Contacts

Public ContactGargi Das

Cancer Institute Adyar (W.I.A)

gargidas@cancerinstitutewia.org9872815856

Outcome results

None listed

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