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Clinical Trials/CTRI/2024/01/061179
CTRI/2024/01/061179
Not yet recruiting
Phase 3

asogastric 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

Cancer Institute Adyar (W.I.A)0 sites0 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Cancer Institute Adyar (W.I.A)
Status
Not yet recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Cancer Institute Adyar (W.I.A)

Eligibility 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

  • •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.

Outcomes

Primary Outcomes

Not specified

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