Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT07035132
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-10-07
First Post:
2025-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Specific Oligomeric Supplementation in Oncologic Patients Undergoing Radiotherapy With Malnutrition or at Risk.
Sponsor:
Outcomes'10
Organization:
Study Overview
Official Title:
Effects of the Specific Supplementation (100% Seric Hydrolized Lactoprotein and MCT) in Malnourished Oncologic Patients Undergoing Radiotherapy
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NORMA
Brief Summary:
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.
Detailed Description:
The prevalence of malnutrition is high in cancer patients: about 80% of patients will suffer from malnutrition at some point, and it is the cause of 10-20% of deaths in this type of patient.
To address malnutrition in these patients, international clinical guidelines recommend periodically reviewing their nutritional status and supplementing with oral nutrition formulas (ONS) when they are unable to meet their nutritional needs from their usual diet.
The ONSs have a nutrient composition designed to meet the specific needs of the patient, but there are pathologies, types of tumours and treatments, such as radiotherapy, chemotherapy, immunotherapy and others that can alter the digestion process, making it difficult for the gastrointestinal tract to utilise nutrients. Patients with these pathologies often cannot tolerate polymeric SNO formulations and require oligomeric peptide-based diet (PBD) formulations.
PBDs contain hydrolysed proteins in the form of peptides and medium-chain triglycerides (MCTs), which are more easily assimilated, helping patients to reduce weight loss and improve overall nutritional status. In addition, they contain hydrolysed serum lactoprotein with high biological quality that stimulates the formation of muscle tissue, minimising cachexia.
Radio/chemotherapy/immunotherapy treatment has negative effects on the nutritional and functional status of cancer patients, which also makes them more susceptible to the toxicities of cancer treatments and clinical complications. It has been shown that these patients tolerate PBD formulas well and even reduce their baseline intestinal symptoms, which facilitates compliance with nutritional treatment. However, adherence to these treatments remains a challenge as it is not always optimal, resulting in the non-achievement of the potential benefits.
The main objective of the study is to evaluate the effects of a hypercaloric SNO, with 100% hydrolysed serum lactoprotein and high MCT intake, in cancer patients undergoing radiotherapy, malnourished or at risk of malnutrition, in terms of improving the patient's nutritional status after 12 weeks of treatment.
To address malnutrition in these patients, international clinical guidelines recommend periodically reviewing their nutritional status and supplementing with oral nutrition formulas (ONS) when they are unable to meet their nutritional needs from their usual diet.
The ONSs have a nutrient composition designed to meet the specific needs of the patient, but there are pathologies, types of tumours and treatments, such as radiotherapy, chemotherapy, immunotherapy and others that can alter the digestion process, making it difficult for the gastrointestinal tract to utilise nutrients. Patients with these pathologies often cannot tolerate polymeric SNO formulations and require oligomeric peptide-based diet (PBD) formulations.
PBDs contain hydrolysed proteins in the form of peptides and medium-chain triglycerides (MCTs), which are more easily assimilated, helping patients to reduce weight loss and improve overall nutritional status. In addition, they contain hydrolysed serum lactoprotein with high biological quality that stimulates the formation of muscle tissue, minimising cachexia.
Radio/chemotherapy/immunotherapy treatment has negative effects on the nutritional and functional status of cancer patients, which also makes them more susceptible to the toxicities of cancer treatments and clinical complications. It has been shown that these patients tolerate PBD formulas well and even reduce their baseline intestinal symptoms, which facilitates compliance with nutritional treatment. However, adherence to these treatments remains a challenge as it is not always optimal, resulting in the non-achievement of the potential benefits.
The main objective of the study is to evaluate the effects of a hypercaloric SNO, with 100% hydrolysed serum lactoprotein and high MCT intake, in cancer patients undergoing radiotherapy, malnourished or at risk of malnutrition, in terms of improving the patient's nutritional status after 12 weeks of treatment.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: