Evaluation of the Effect of an Specific Oral Nutritional Supplement on the Nutritional Status in … (NCT04184713) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Effect of an Specific Oral Nutritional Supplement on the Nutritional Status in Cancer and Malnutrition
Spain160 participantsStarted 2019-10-01
Plain-language summary
Effect of a specific nutritional oral supplement on the nutritional status of patients with cancer and malnutrition
Who can participate
Age range28 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Nutritional status
Timeframe: Change from baseline to day 142
Trial details
NCT IDNCT04184713
SponsorInstituto de Investigación Hospital Universitario La Paz