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

Instituto de Investigación Hospital Universitario La Paz

Status

Completed

Conditions

Malnutrition

Cancer

Nutrition Related Cancer

Treatments

Dietary Supplement: Experimental Group

Dietary Supplement: Control Group

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04184713

HULP 5358

Details and patient eligibility

About

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

Full description

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).

Enrollment

160 patients

Sex

All

Ages

28+ years old

Volunteers

No Healthy Volunteers

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