Omega-3 fatty acids supplementation improve nutritional status and inflammatory response in patients with lung cancer: a randomized clinical trial

Last registered on February 12, 2021

Pre-Trial

Trial Information

General Information

Title
Omega-3 fatty acids supplementation improve nutritional status and inflammatory response in patients with lung cancer: a randomized clinical trial
RCT ID
AEARCTR-0007165
Initial registration date
February 11, 2021
Last updated
February 12, 2021, 11:02 AM EST

Locations

Region

Primary Investigator

Affiliation
Anhui Medical University

Other Primary Investigator(s)

Additional Trial Information

Status
Completed
Start date
2019-02-01
End date
2020-09-01
Secondary IDs
Abstract
Background & aims: Clinical studies have reported positive results with omega-3 supplements in oncologic patients. The aim of this study was to evaluate the efficacy of Omega-3 fatty acids supplementation in improving nutritional status and inflammatory markers of patients with lung cancer.
Methods: In a randomized double blind parallel design trial, sixty patients with lung cancer at nutritional status risk based on Nutrition Risk Screening 2002 were randomized to be allocated to two study groups, receiving omega 3 fatty acids supplement (EPA 1.6 g and DHA 0.8 g) or placebo for 12 weeks. Anthropometric measurements (weight, BMI, upper-arm circumference, and triceps skinfold thickness), nutritional based laboratory indices (hemoglobin, albumin, triglyceride, cholesterol), and inflammatory markers (CRP, TNF alpha, and IL-6) were measured before and after the intervention as study outcomes.
External Link(s)

Registration Citation

Citation
Huo, Qianlun . 2021. "Omega-3 fatty acids supplementation improve nutritional status and inflammatory response in patients with lung cancer: a randomized clinical trial." AEA RCT Registry. February 12. https://doi.org/10.1257/rct.7165-1.0
Experimental Details

Interventions

Intervention(s)
Omega-3 fatty acids supplementation gel capsules (EPA 1.6 g and DHA 0.8 g), or placebo gel capsules (sunflower oil) with similar appearance (supplied by Sinadaro, China) were provided to the patients for 12 weeks of intervention. The patients’ compliance was evaluated by a form marked on each day of taking capsules. Patients with more than 3 lost dose was excluded from the analysis.
Intervention Start Date
2019-02-01
Intervention End Date
2020-09-01

Primary Outcomes

Primary Outcomes (end points)
Anthropometric measurements (weight, BMI, upper-arm circumference, and triceps skinfold thickness), nutritional based laboratory indices (hemoglobin, albumin, triglyceride, cholesterol), and inflammatory markers (CRP, TNF alpha, and IL-6) were measured before and after the intervention as study outcomes.
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
The study was designed as a double-blinded placebo-controlled randomized clinical trial including two-arms with parallel design. No change was made in methods after trial commencement.
Experimental Design Details
Randomization Method
Sixty eligible patients were randomly allocated to the two study groups by the clinic secretary based on randomization list. The list was created by block randomization method. The oncologist, nutritionist, and secretary all kept blind to patients’ group assignment. Patients also remained blind to the treatment groups by similarity in the shape, colour and size of gel capsules and bottles of omega-3 fatty acids and placebo.
Randomization Unit
individual
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
60
Sample size: planned number of observations
60
Sample size (or number of clusters) by treatment arms
30
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials