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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04184713
• Other study ID #: HULP 5358
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: September 2019
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Malnutrition
• Nutrition Related Cancer

Intervention

Dietary Supplement:
• Experimental Group
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
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.

Locations

Country	Name	City	State
Spain	Institute for Health Research IdiPAZ	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz	Adventia Pharma, S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional status	Subjective Global Assessment (SGA)	Change from baseline to day 142
Secondary	Diet quality	72h food registry questionaire	Change from baseline to day 142
Secondary	Functional status	Dinamometer	Change from baseline to day 142
Secondary	Eastern Cooperative Oncology Group Scale (ECOG)	Eastern Cooperative Oncology Group Scale (ECOG)	Change from baseline to day 142
Secondary	Body composition	BIA	Change from baseline to day 142