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

Not Applicable

Completed

• Conditions: Cancer; Malnutrition; Nutrition Related Cancer
• Interventions: Dietary Supplement: Control Group; Dietary Supplement: Experimental Group

• Registration Number: NCT04184713
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

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).

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-12
• Study Start: 2019-10-01
• Study First Submitted QC: 2019-11-29
• Study First Posted: 2019-12-04
• Primary Completion: 2020-08-01
• Study Completion: 2020-08-01
• Last Update Submitted: 2021-07-18
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control Group	Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement
Experimental Group	Experimental Group	Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement

Primary Outcome Measures

Name	Time	Method
Nutritional status	Change from baseline to day 142	Subjective Global Assessment (SGA)

Secondary Outcome Measures

Name	Time	Method
Eastern Cooperative Oncology Group Scale (ECOG)	Change from baseline to day 142	Eastern Cooperative Oncology Group Scale (ECOG)
Body composition	Change from baseline to day 142	BIA
Diet quality	Change from baseline to day 142	72h food registry questionaire
Functional status	Change from baseline to day 142	Dinamometer

Trial Locations

Locations (1)

Institute for Health Research IdiPAZ; 🇪🇸 Madrid, Spain