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Impact of Specific Oligomeric Supplementation in Oncologic Patients Undergoing Radiotherapy With Malnutrition or at Risk.

Study acronym: NORMA
StatusEnrolling by Invitation
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 7, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Study sites: 0 to 4
    • Start date changed from estimate of Jul 1, 2025 to Aug 15, 2025
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
An observational, prospective, multicenter study to be conducted in 5 hospitals in Spain. Patients with cancer undergoing radiotherapy are malnourished or at risk of malnutrition. Due to the characteristics of their pathology or gastrointestinal disorders, the use of oligomeric nutritional formulas formulated with 100% hydrolyzed whey lactoprotein and a high MCT content is recommended as part of routine clinical practice. Patients will be followed for 12 weeks, with three visits: a baseline visit upon inclusion in the study, after 6 weeks and a final visit 12 weeks after the nutritional treatment starts.
Trial Details
NCT Number NCT07035132
Lead Sponsor Outcomes'10
Collaborators: Nestlé Health Science Spain
Conditions
(from sponsor)		 Malnutrition in Elderly, Oncological Patients, Digestive Disorders
Related terms Digestive System Diseases
Enrollment 132 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov