NCT05837741

Brief Summary

Currently there is a lack of evidence for recommending specific oral supplements (OS) for nutritional support in patients with cancer, including leucine-enriched supplements.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

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

Study Start

First participant enrolled

March 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

April 1, 2023

Last Update Submit

May 6, 2023

Conditions

SarcopeniaCancer

Keywords

SarcopeniaCancer

Outcome Measures

Primary Outcomes (1)

  • Muscle mass gain

    Changes in Muscle mass (%) determined by BIA and echography

    3 Months

Secondary Outcomes (5)

  • Fat mass change

    3 Months

  • Phase angle change

    3 Months

  • Changes in albumin

    3 Months

  • Changes in prealbumin

    3 Months

  • Changes in CRP

    3 Months

Study Arms (2)

Standard hypercaloric, hyperproteic oral supplement

ACTIVE COMPARATOR

Patients will receive 2 supplements per day (Standard hypercaloric, hyperproteic oral supplement)

Dietary Supplement: Standard hypercaloric hyperproteic oral nutritional supplement

Leucin-enriched hypercaloric, hyperproteic oral supplement

ACTIVE COMPARATOR

Patients will receive 2 supplements per day (Leucin-enriched hypercaloric, hyperproteic oral supplement)

Dietary Supplement: Leucine-enriched hypercaloric hyperproteic oral nutritional supplement

Interventions

Standard hypercaloric hyperproteic oral nutritional supplementDIETARY_SUPPLEMENT

Patients will receive nutritional support with Standard hypercaloric hyperproteic oral nutritional supplement

Standard hypercaloric, hyperproteic oral supplement
Leucine-enriched hypercaloric hyperproteic oral nutritional supplementDIETARY_SUPPLEMENT

Patients will receive nutritional support with Leucine-enriched hypercaloric hyperproteic oral nutritional supplement

Leucin-enriched hypercaloric, hyperproteic oral supplement

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients of both sexes, age \> 18 y-old
  • cancer of different origin treated with systemic treatment chemo, radiotherapy or combination treatment t
  • weight loss \>5% during the previous three months or \>10% during the previous six months

You may not qualify if:

  • end-stage kidney disease
  • life expectancy \< 2 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IMIBIC

Córdoba, Cordoba, 14004, Spain

Location

MeSH Terms

Conditions

SarcopeniaNeoplasms

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Aura D Herrera Martinez, PhD

    IMIBIC-HURS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 1, 2023

First Posted

May 1, 2023

Study Start

March 1, 2021

Primary Completion

August 1, 2021

Study Completion

November 1, 2021

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)