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

Sponsor

Instituto de Investigación Hospital Universitario La Paz (Other)

Overall Status

Completed

CT.gov ID

NCT04184713

Collaborator

Adventia Pharma, S.L. (Other)

160

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Malnutrition Cancer Nutrition Related Cancer	Dietary Supplement: Experimental Group Dietary Supplement: Control Group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Oct 1, 2019

Actual Primary Completion Date :

Aug 1, 2020

Actual Study Completion Date :

Aug 1, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Nutritional status [Change from baseline to day 142]
Subjective Global Assessment (SGA)

Secondary Outcome Measures

Diet quality [Change from baseline to day 142]
72h food registry questionaire
Functional status [Change from baseline to day 142]
Dinamometer
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

28 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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