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Completed

NCT Number: NCT04184713

Evaluation of the Effect of an Specific Oral Nutritional Supplement on the Nutritional Status in Cancer and Malnutrition

Effect of a specific nutritional oral supplement on the nutritional status of patients with cancer and malnutrition

Completed

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Key information

Age range

28 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Health Research IdiPAZ

Madrid, 28046, Spain

About this study

Multicentric, parallel, randomized, double blind and controlled clinical-nutritional study of 8 weeks of duration and 2 study groups of treatment: Experimental group (experimental nutritional oral supplement); and Control group (control nutritional oral supplement) to evaluate the effect on the nutritional and functional status, the quality of life and body composition of patients with cancer and malnutrition undergoint specficic treatment (chemotherapy, radiotherapy, inmunotherapy).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women over 18 with a cancer diagnosis (any type).
  • Subjects who have initiated during the next mont a treatment with chemo and or radiotherapy with or without surgery.
  • Having lost more than 5% of body weight in the last 6 months.
  • Adequate cultural level and understanding for the clinical trial.
  • Signed informed consent.

Exclusion criteria

  • Subjects who are participating in other clinical trials.
  • Subjects with morbid obesity.
  • Subjects who will undergo surgery or who will undergo.
  • Subjects with cachexia
  • Subjects with infection of a cause other than of the tumor
  • Subjects with an infectious process
  • Subjects with Diabetes Mellitus treated with insulin and/or not controlled
  • Subjects with kidney, heart, respiratory or liver disease.
  • Subjects with autoimmune diseases.
  • Subjects with mental illness or decrease function cognitive.
  • Subjects who consume oral supplements or artificial nutrition and who cannot be withdran at least 1 week before startint the study.
  • Patients who have consumed food supplements or fortified foods in omega 3 (arginine or nucleotides) during the previous month.
  • Patients who reject oral supplements.
  • Pregnant or breastfeeding women.
  • Allergic to any component of the formula

Treatment and study plan

Experimental Group

Dietary Supplement

Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement (hypercaloric/hyperproteic with fiber and omega-3 enriched, with L-leucine, betaglucans and medium chain triglycerides) for 8 weeks.

Control group

Dietary Supplement

Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement (hypercaloric/hyperproteic with fiber) for 8 weeks.

Primary outcomes

  1. Nutritional status

    Time frame: Change from baseline to day 142

    Subjective Global Assessment (SGA)

Secondary outcomes

  1. Diet quality

    Time frame: Change from baseline to day 142

    72h food registry questionaire

  2. Functional status

    Time frame: Change from baseline to day 142

    Dinamometer

  3. Eastern Cooperative Oncology Group Scale (ECOG)

    Time frame: Change from baseline to day 142

    Eastern Cooperative Oncology Group Scale (ECOG)

  4. Body composition

    Time frame: Change from baseline to day 142

    BIA

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Collaborators

  • Adventia Pharma

Registry information

Official study title

A Clinical Trial With Nutritional Intervention to Evaluate the Effect of an Specific Oral Nutritional Supplement on the Nutritional Status in Patients With Cancer and Malnutrition

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2019
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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