NCT04965129

Brief Summary

This study is conducted to test the hypothesis that patients with lung cancer undergoing treatment with immunotherapy, chemotherapy and tyrosine Kinase Inhibitors receiving a high protein diet and supplemented with fish oil will improve muscle mass, therapeutic response and modulate the intestinal microbiota within a 4 month period.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
1.3 years until next milestone

Study Start

First participant enrolled

November 15, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

1.5 years

First QC Date

May 20, 2021

Last Update Submit

May 15, 2024

Conditions

Lung Cancer

Keywords

fish oilsbody compositionmicrobiotaepigeneticslung cancer

Outcome Measures

Primary Outcomes (1)

  • Change in muscle mass

    CT-derived changes in muscle mass ocurring from baseline to week 16

    16 weeks

Secondary Outcomes (5)

  • Red blood cell omega-3 fatty acid concentrations (eicosapentaenoic [EPA] and docosahexaenoic acid [DHA]

    16 weeks

  • Muscle strenght

    16 weeks

  • Change in fecal microbiome composition

    16 weeks

  • Change in levels of miRNA 133

    16 weeks

  • Change/maintenance in overall skeletal muscle density.

    16 weeks

Study Arms (2)

Placebo Comparator: Placebo

PLACEBO COMPARATOR

Placebo Comparator: Placebo All subjects will be given placebo identically matched with regard to shape, color and taste. They will be given four tablet/day for four mounths.

Drug: Placebo

Experimental: Fish oil

EXPERIMENTAL

All subjects will be given fish oil with a dose of 2.100 mg of EPA and 924 mg of DHA, in four tablet twice daily for four mounths.

Drug: Fish oil

Interventions

PlaceboDRUG

Drug: Placebo olive oil pill manufactured to mimic fish oil. Other Names: • Placebo

Placebo Comparator: Placebo
Fish oilDRUG

All subjects will be given fish oil with a dose of of 2.100 mg of EPA and 924 mg of DHA, in four tablet twice daily for four mounths.

Also known as: Vital Fish
Experimental: Fish oil

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of non-small cell lung cancer, both sexes, ECOG performance status (0-2) eligible for treatment with immunotherapy, chemotherapy and tyrosine Kinase Inhibitors.

You may not qualify if:

  • supplementation of PUFA n-3 in the last 6 months; weight loss\> 10% in 6 months, chronic liver disease, previous chronic kidney disease, anorexia, decompensated diabetes mellitus and dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 21941913, Brazil

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Wilza AF Peres, PhD

    Post-graduation in Nutrition, Institute of Nutrition

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wilza AF Peres, PhD

CONTACT

552139386432wilza@nutricao.ufrj.br

Imanuely B Gonçalves, MsC

CONTACT

552134396432imanuely.goncalves@oncoclinicas.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, Institute of Nutrition

Study Record Dates

First Submitted

May 20, 2021

First Posted

July 16, 2021

Study Start

November 15, 2022

Primary Completion

May 1, 2024

Study Completion

March 15, 2025

Last Updated

May 17, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)