NCT04184713

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

July 20, 2021

Status Verified

September 1, 2019

Enrollment Period

10 months

First QC Date

September 12, 2019

Last Update Submit

July 18, 2021

Conditions

MalnutritionCancerNutrition Related Cancer

Keywords

malnutritioncancernutritionnutritional oral supplementclinical trial

Outcome Measures

Primary Outcomes (1)

  • Nutritional status

    Subjective Global Assessment (SGA)

    Change from baseline to day 142

Secondary Outcomes (4)

  • Diet quality

    Change from baseline to day 142

  • Functional status

    Change from baseline to day 142

  • Eastern Cooperative Oncology Group Scale (ECOG)

    Change from baseline to day 142

  • Body composition

    Change from baseline to day 142

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Dietary Supplement: Experimental Group

Control group

ACTIVE COMPARATOR

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

Dietary Supplement: Control Group

Interventions

Experimental GroupDIETARY_SUPPLEMENT

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.

Experimental Group
Control GroupDIETARY_SUPPLEMENT

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.

Control group

Eligibility Criteria

Age28 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Health Research IdiPAZ

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

MalnutritionNeoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Carmen Gómez Candela, Msc

    Hospital Universitario La Paz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2019

First Posted

December 4, 2019

Study Start

October 1, 2019

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

July 20, 2021

Record last verified: 2019-09

Locations

ES(1)