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

NCT07035132 | Enrolling By Invitation DMC

• 1 other identifier: NES-2023-154-PRO-PEP
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 4

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.

Conditions

Malnutrition in Elderly; Oncological Patients; Digestive Disorders

Keywords

nutritional supplementation; radiotherapy; malabsortion; oligomeric formula

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• Percentage of patients with improvement in the degree of malnutrition

  From enrollment to the end of treatment at 12 weeks

• Percentage change in BMI

  From enrollment to the end of treatment at 12 weeks

• Arm circumference

  From enrollment to the end of treatment at 12 weeks

• Calf circumference

  From enrollment to the end of treatment at 12 weeks

• Maximum prehensile strength value

  From enrollment to the end of treatment at 12 weeks

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Outcomes'10: lead
• Nestlé Health Science Spain: collaborator

Study Sites (4)

Hospital Universitario San Juan de Alicante

Alicante, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Location

HU Clinica Asturias

Oviedo, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, Spain

Location

MeSH Terms

Conditions

Digestive System Diseases

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 24, 2025
• Study Start: August 15, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)