Impact of Specific Oligomeric Supplementation in Oncologic Patients Undergoing Radiotherapy With Malnutrition or at Risk.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oral supplementation with nutritional oligomeric formula.
- Who it may be relevant to
- Registry conditions: Malnutrition in Elderly, Oncological Patients, Digestive Disorders. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of the Specific Supplementation (100% Seric Hydrolized Lactoprotein and MCT) in Malnourished Oncologic Patients Undergoing Radiotherapy
Overview
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.
Interventions
- Dietary supplement Oral supplementation with nutritional oligomeric formula
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.
Primary outcome measures
- Percentage of patients who improve the degree of malnutrition. [Time frame: From enrollment to the end of treatment at 12 weeks]
Secondary outcome measures (12)
- Percentage of patients with improvement in the degree of malnutrition [Time frame: From enrollment to the end of treatment at 12 weeks]
- Percentage change in BMI [Time frame: From enrollment to the end of treatment at 12 weeks]
- Arm circumference [Time frame: From enrollment to the end of treatment at 12 weeks]
- Calf circumference [Time frame: From enrollment to the end of treatment at 12 weeks]
- Maximum prehensile strength value [Time frame: From enrollment to the end of treatment at 12 weeks]
- Sit-to-stand test [Time frame: From enrollment to the end of treatment at 12 weeks]
- Impedancemetry values [Time frame: From enrollment to the end of treatment at 12 weeks]
- Percentage of patients presenting complications associated with nutritional status during treatment. [Time frame: 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 [Time frame: After 6 and after 12 weeks of treatment]
- Distribution of the patients according to their compliance with the treatment [Time frame: At 6 and 12 weeks of treatment.]
- Distribution of the patients according to their adherence to the treatment [Time frame: At 6 and 12 weeks of treatment.]
- Percentage of patients who maintain or improve their quality of life after 12 weeks of treatment. [Time frame: After 12 weeks of treatment.]
Eligibility criteria
Inclusion criteria
- Patients of legal age (≥18 years).
- Oncology patients (with head and neck, lung or rectal cancer) undergoing or about to start radiotherapy treatment. Patients with oesophageal cancer will also be included, as long as the patient is not undergoing PEG.
- Patients who are malnourished or at risk of malnutrition according to GLIM criteria.
- Patients requiring supplementation with an oligomeric formula with 100% hydrolysed serum lactoprotein and high MCT intake due to gastrointestinal disturbances (either maldigestion or maldigestion, malabsorption or dysmotility) intolerance to polymeric formulations or any other reason as considered by the physician.
- Patients who, at the discretion of the investigator, have the ability to answer the questionnaires and follow the procedures detailed in the protocol.
- Patients who give written informed consent to participate.
Exclusion criteria
- Patients with galactosemia, allergies and/or intolerances to lactose or any of the compounds of the formula.
- Patients receiving nutritional support other than that of the study characteristics or who have received it during the last month. It will be accepted in patients who, being on a polymeric SNO, are advised to change to the oligomeric formula under study, due to gastrointestinal alterations, intolerances or any other reason considered by the doctor.
- Patients who have undergone surgery in the last three months.
- Patients who have received Enteral Nutrition in the last 3 months for SNG/SNJ/PEG.
- Pregnant or lactating women.
- Patients with advanced renal or hepatic disease (with creatinine clearance less than 45 ml/min or CP=C).
- Patients with advanced neoplastic disease with life expectancy <3 months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 4 centers
- Hospital Universitario San Juan de Alicante — Alicante
- Hospital Universitario Fundación Jiménez Díaz — Madrid
- HU Clinica Asturias — Oviedo
- Hospital Universitario Son Espases — Palma de Mallorca
Identifiers
NCT: NCT07035132 · NES-2023-154-PRO-PEP