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Enteral Omega 3 During Radiotherapy to Improve the Quality of Life and Functionality of Head and Neck Cancer Patients

NCT03720158 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-07-25

No results posted yet for this study

Summary

Health-related Quality of Life (QoL) is a multidimensional construct that allows us to know the patient's perception of well-being, and how this perception is related to their illness and treatment. In clinical research, especially clinical trials, the QoL measurement has become an important element to evaluate. In patients with Head and Neck Squamous Cell Carcinoma (HNSCC), low QoL is associated with Malnutrition (MN), and Cancer Cachexia (CC) is a principal component in its multifactorial etiology. The exacerbated hypercatabolic state of CC is caused by the increase of pro-inflammatory cytokines, Reactive Oxygen Species (ROS), and other catabolic mediators. The clinical manifestation of CC is a continuous decrease in muscle mass (with or without loss of fat mass), which is not entirely reversible with nutritional support and which leads to the functional deterioration of patients. Due to CC, the patients with HNSCC who receive total enteral nutritional support have difficulties in maintaining an optimal nutritional status, and this situation is more frequent during RadioTherapy (RT). An immune-modulator nutrient, Omega-3 fatty acids (O3) have shown efficacy in improving the nutritional and inflammatory parameters of patients with HNSCC; however, little is known about their impact on patients' QoL and Functionality (Fx). Therefore, this clinical trial is proposed to provide information about the usefulness of O3 for improving the Fx and QoL of patients with HNSCC receiving total enteral nutrition during RT.

Conditions

Interventions

DIETARY_SUPPLEMENT

Omega 3 Group

Five mL of an Omega-3 highly concentrated substance (containing 2.25 g of EPA and 1.08 g of DHA) will be added daily to the standard enteral diet during the entire radiotherapy

DIETARY_SUPPLEMENT

Placebo or Control Group

Five mL of pigmented and flavored corn oil will be added daily to the standard enteral diet during the entire radiotherapy treatment period (from 5-7 weeks)

Sponsors & Collaborators

  • Coordinación de Investigación en Salud, Mexico

    lead OTHER_GOV

Principal Investigators

  • Luz Ma. Adriana Balderas-Peña, PhD · Unidad de Investigación Biomédica 02, UMAE HE CMNO IMSS

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-10
Primary Completion
2021-07-31
Completion
2021-07-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03720158 on ClinicalTrials.gov