Clinical trial NCT04184713: Evaluation of the Effect of an Specific Oral Nutritional Supplement on the Nutritional Status in Cancer and Malnutrition
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Cancer
Nutrition Related Cancer
Keywords: malnutrition
cancer
nutrition
nutritional oral supplement
clinical trial
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Adventia Pharma
First posted: 2019-12-04
Enrollment: 160
Sex: ALL
Minimum age (years): 28
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Nutritional status
timeFrame: Change from baseline to day 142
Secondary outcomes:
measure: Diet quality
timeFrame: Change from baseline to day 142
measure: Functional status
timeFrame: Change from baseline to day 142
measure: Eastern Cooperative Oncology Group Scale (ECOG)
timeFrame: Change from baseline to day 142
measure: Body composition
timeFrame: Change from baseline to day 142
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Institute for Health Research IdiPAZ
Study officials:
affiliation: Hospital Universitario La Paz
name: Carmen Gómez Candela, Msc
role: PRINCIPAL_INVESTIGATOR
References: