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| Name | Class |
|---|---|
| Nestlé Health Science Spain | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral supplementation with nutritional oligomeric formula | Dietary Supplement | Patients will be supplemented with the specific oligomeric formula (1 or 2 bottles/day, as per investigator's decision) during, at least, the 12 weeks of the study follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who improve the degree of malnutrition. | According to body weight, after 12 weeks of treatment with SNO with 100% hydrolyzed serum lactoprotein and high MCT intake. | From enrollment to the end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with improvement in the degree of malnutrition | According to GLIM criteria after 12 weeks of treatment with SNO with 100% hydrolyzed serum lactoprotein and high MCT intake. | From enrollment to the end of treatment at 12 weeks |
| Percentage change in BMI |
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Inclusion Criteria:
Exclusion Criteria:
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Oncological patients undergoing radiotherapy, who present malnutrition or risk of malnutrition and due to the characteristics of the pathology or gastrointestinal alterations, the use of oligolimeric nutritional formulas formulated with 100% hydrolyzed serum lactoprotein and high MCT content is recommended within the usual clinical practice.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario San Juan de Alicante | Alicante | Spain | ||||
| Hospital Universitario Fundación Jiménez Díaz |
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Weight and height will be combined to report BMI in kg/m². |
| From enrollment to the end of treatment at 12 weeks |
| Arm circumference | Is measured in CM | From enrollment to the end of treatment at 12 weeks |
| Calf circumference | Is measured in CM | From enrollment to the end of treatment at 12 weeks |
| Maximum prehensile strength value | Using a dynamometer, an instrument that measures force in kilograms. | From enrollment to the end of treatment at 12 weeks |
| Sit-to-stand test | Is measured primarily by counting the number of repetitions a person can perform while standing up and sitting in a chair in a specified period of time, such as 30 seconds. | From enrollment to the end of treatment at 12 weeks |
| Impedancemetry values | Probe. | From enrollment to the end of treatment at 12 weeks |
| Percentage of patients presenting complications associated with nutritional status during treatment. | Changes in oncological treatment, hospital admissions or visits to the emergency room are considered complications. | From enrollment to the end of treatment at 12 weeks |
| Percentage of patients presenting changes in gastrointestinal tolerance after 6 and after 12 weeks of treatment with SNO with 100% hydrolyzed serum | After 6 and after 12 weeks of treatment with SNO with 100% hydrolyzed serum lactoprotein and high MCT intake. | After 6 and after 12 weeks of treatment |
| Distribution of the patients according to their compliance with the treatment | With SNO with 100% hydrolyzed serum lactoprotein and high MCT intake. | At 6 and 12 weeks of treatment. |
| Distribution of the patients according to their adherence to the treatment | (low: 0-2 points, medium: 3-4 points or high: 5-6 points) | At 6 and 12 weeks of treatment. |
| Percentage of patients who maintain or improve their quality of life after 12 weeks of treatment. | Improve their quality of life. | After 12 weeks of treatment. |
| Percentage of patients satisfied with the product | With SNO with 100% hydrolyzed serum lactoprotein and high MCT content. | After 12 weeks of treatment with SNO |
| Average health care expenditure per patient, according to degree of malnutrition, during the study. | Health expenditure per patient | From enrollment to the end of treatment at 12 weeks |
| Madrid |
| Spain |
| HU Clinica Asturias | Oviedo | Spain |
| Hospital Universitario Son Espases | Palma de Mallorca | Spain |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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