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

Instituto de Investigación Hospital Universitario La Paz1 site in 1 country160 target enrollmentOctober 1, 2019

ConditionsMalnutrition Cancer Nutrition Related Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Malnutrition
Sponsor: Instituto de Investigación Hospital Universitario La Paz
Enrollment: 160
Locations: 1
Primary Endpoint: Nutritional status
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

October 1, 2019

End Date

August 1, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Nutritional status

Time Frame: Change from baseline to day 142

Subjective Global Assessment (SGA)

Secondary Outcomes

Eastern Cooperative Oncology Group Scale (ECOG)(Change from baseline to day 142)
Body composition(Change from baseline to day 142)
Diet quality(Change from baseline to day 142)
Functional status(Change from baseline to day 142)