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

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

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

Study Overview

• Status: Completed
• Conditions: Cancer; Malnutrition; Nutrition Related Cancer
• Intervention / Treatment: Dietary supplement: Experimental Group; Dietary supplement: Control Group

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Institute for Health Research IdiPAZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement	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.
Active Comparator: Control group; Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional status	Subjective Global Assessment (SGA)	Change from baseline to day 142

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Collaborators: Adventia Pharma

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: November 29, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 18, 2021
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: cancer; nutrition; clinical trial; malnutrition; nutritional oral supplement
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: HULP 5358

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No