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

Primary Purpose

Malnutrition, Cancer, Nutrition Related Cancer

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental Group
Control Group
Sponsored by
Instituto de Investigación Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malnutrition focused on measuring malnutrition, cancer, nutrition, nutritional oral supplement, clinical trial

Eligibility Criteria

28 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institute for Health Research IdiPAZ

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control group

Arm Description

Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement

Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement

Outcomes

Primary Outcome Measures

Nutritional status
Subjective Global Assessment (SGA)

Secondary Outcome Measures

Diet quality
72h food registry questionaire
Functional status
Dinamometer
Eastern Cooperative Oncology Group Scale (ECOG)
Eastern Cooperative Oncology Group Scale (ECOG)
Body composition
BIA

Full Information

First Posted
September 12, 2019
Last Updated
July 18, 2021
Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Adventia Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT04184713
Brief Title
Evaluation of the Effect of an Specific Oral Nutritional Supplement on the Nutritional Status in Cancer and Malnutrition
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Adventia Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Cancer, Nutrition Related Cancer
Keywords
malnutrition, cancer, nutrition, nutritional oral supplement, clinical trial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Experimental Group
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Control Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nutritional status
Description
Subjective Global Assessment (SGA)
Time Frame
Change from baseline to day 142
Secondary Outcome Measure Information:
Title
Diet quality
Description
72h food registry questionaire
Time Frame
Change from baseline to day 142
Title
Functional status
Description
Dinamometer
Time Frame
Change from baseline to day 142
Title
Eastern Cooperative Oncology Group Scale (ECOG)
Description
Eastern Cooperative Oncology Group Scale (ECOG)
Time Frame
Change from baseline to day 142
Title
Body composition
Description
BIA
Time Frame
Change from baseline to day 142

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Gómez Candela, Msc
Organizational Affiliation
Hospital Universitario La Paz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Health Research IdiPAZ
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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