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Malnutrition in ElderlyNORMANCT07035132

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

An observational study of Malnutrition in Elderly and Oncological Patients, run by Outcomes'10 at 4 sites in Spain.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Oral supplementation with nutritional oligomeric formula
Type of treatment
Pill or oral medicine
How many people
132 participants
Where
4 sitesSpain
Study dates
15 Aug 2025to 31 Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Spain4 sites

  • Hospital Universitario San Juan de Alicante

    Alicante

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid

  • HU Clinica Asturias

    Oviedo

  • Hospital Universitario Son Espases

    Palma de Mallorca

Other trials in Spain

About this study

Official title: Effects of the Specific Supplementation (100% Seric Hydrolized Lactoprotein and MCT) in Malnourished Oncologic Patients Undergoing Radiotherapy

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.

Read the 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.

Being tested
Oral supplementation with nutritional oligomeric formula
Keywords
nutritional supplementation, radiotherapy, malabsortion, oligomeric formula
Medical subject headings
Digestive System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral supplementation with nutritional oligomeric formulaDietary 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to the end of treatment at 12 weeks

Secondary outcomes (14)

  1. 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  2. Percentage change in BMI

    Weight and height will be combined to report BMI in kg/m².

    Measured: From enrollment to the end of treatment at 12 weeks

  3. Arm circumference

    Is measured in CM

    Measured: From enrollment to the end of treatment at 12 weeks

  4. Calf circumference

    Is measured in CM

    Measured: From enrollment to the end of treatment at 12 weeks

  5. Maximum prehensile strength value

    Using a dynamometer, an instrument that measures force in kilograms.

    Measured: From enrollment to the end of treatment at 12 weeks

  6. 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  7. Impedancemetry values

    Probe.

    Measured: From enrollment to the end of treatment at 12 weeks

  8. 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  9. 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.

    Measured: After 6 and after 12 weeks of treatment

  10. Distribution of the patients according to their compliance with the treatment

    With SNO with 100% hydrolyzed serum lactoprotein and high MCT intake.

    Measured: At 6 and 12 weeks of treatment.

  11. Distribution of the patients according to their adherence to the treatment

    (low: 0-2 points, medium: 3-4 points or high: 5-6 points)

    Measured: At 6 and 12 weeks of treatment.

  12. Percentage of patients who maintain or improve their quality of life after 12 weeks of treatment.

    Improve their quality of life.

    Measured: After 12 weeks of treatment.

  13. Percentage of patients satisfied with the product

    With SNO with 100% hydrolyzed serum lactoprotein and high MCT content.

    Measured: After 12 weeks of treatment with SNO

  14. Average health care expenditure per patient, according to degree of malnutrition, during the study.

    Health expenditure per patient

    Measured: From enrollment to the end of treatment at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2025
  2. Study start15 Aug 2025
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07035132
Sponsor's protocol ID
NES-2023-154-PRO-PEP
Acronym
NORMA
Status last verified
Oct 2025
First submitted
15 May 2025
Last updated
7 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Malnutrition in Elderly and Oncological Patients, run by Outcomes'10 at 4 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients who improve the degree of malnutrition. (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07035132.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.

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