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 treatment period (from 5-7 weeks)

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)

Head and Neck Squamous Cell Carcinoma

Quality of Life

Radiotherapy; Complications

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

Omega 3 Group

Placebo or Control Group

World Health Organization. Estimated crude rate of incident cases, both sexes, worldwide (top 20 cancer sites) in 2012

Unidad de Investigación Biomédica 02, UMAE HE CMNO IMSS

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

Effect of Enteral Supplementation of Omega 3 Fatty Acids on the Quality of Life and Functionality of Patients With Head and Neck Squamous Cell Carcinoma Undergoing Radiotherapy

The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item scales and single-item measures. These include five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status / QoL scale (GHS/QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and difficulties). Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." The principle for scoring these scales is the same in all cases: 1. Estimate the average of the items that contribute to the scale; this is the raw score. 2. Use a linear transformation to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms. A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.

The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item scales and single-item measures. These include the Physical Functioning Scale and four more functional scales (role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status / QoL scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and difficulties). Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." The method for scoring these scales is: 1. Estimate the average of the items that contribute to the scale; this is the raw score. 2. Use a linear transformation to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms. A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.

Changes of the serum levels quantified by means of the Enzyme-Linked ImmunoSorbent Assay (ELISA)

Coordinación de Investigación en Salud, Mexico

Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks

Supplementation of 3.7 g of corn oil per day during 12 weeks

Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks
Omega 3 fatty acids: Omega 3 fatty acids will be provided in a dose of 3.7 g/day, that should be enough to rise red blood cell levels of eicosapentanoic and docosahexanoic acids

Omega 3 Fatty Acids

Supplementation of 3.7 g of corn oil per day during 12 weeks
Corn oil: Corn oil will be the placebo comparator for omega 3 fatty acids supplement

Corn Oil

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Region of Enrollment

Urine albumin excretion

Number of participants in whom urine albumin excretion in a spot urine sample at the end of follow up, expressed as mg/g creatinine, decreased by 20% or more

Number of Participants With a Urine Albumin Excretion Decrease of 20% or More

Blood C reactive protein measured at baseline and the end of the intervention.

Change in C Reactive Protein Levels at 12 Weeks of Intervention

Measurement of pulse wave velocity using a oscillometric device measured at baseline and end of follow up and expressed ad m/s

Change in Pulse Wave Velocity at 12 Weeks of Intervention

Overall Study

Dr. Francisco Perez Bravo, Director

Renal Insufficiency, Chronic

Omega 3 fatty acids will be provided in a dose of 3.7 g/day, that should be enough to rise red blood cell levels of eicosapentanoic and docosahexanoic acids

Omega 3 fatty acids

Corn oil will be the placebo comparator for omega 3 fatty acids supplement

Corn oil

Institute of Nutrition and Food Technology University of Chile

Omega 3 Fatty Acids in Patients With Chronic Renal Disease

Effects of the Supplementation With Omega 3 Fatty Acids in Patients With Chronic Renal Disease

Sharing of information must be discussed with the sponsor

Daniel Bunout

Full profesor

University of Chile

Servicio de Salud Metropolitano Oriente

Participants will be randomly selected to receive 3.7 g of a supplement containing docosahexanoic and eicosapentanoic acids or a supplement containing corn oil. The supplements will be provided for 12 weeks

Identical sachets containind the study supplement or corn oil will be number coded and provided to participants

Dyslipidemia

Diabetes

Prediabetes

Dysglycemia

Gout

Hypertension

Non-alcoholic Fatty Liver Disease

Cardiovascular Disease

An intervention in which calories from fructose-containing sugars are substituted, added, or subtracted in the diet

Fructose-containing Sugars

The Toronto 3D (Diet, Digestive tract and Disease) Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital

Meta-analyses of the Effect of Important Food Sources of Sugars on Cardiometabolic Risk Factors

Effect of Important Food Sources of Fructose-containing Sugars on Cardiometabolic Risk Factors: A Series of Systematic Reviews and Meta-analyses of Controlled Trials to Inform Dietary Guidelines, Public Health Policy, and Future Trial Design

zea/albumin

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

Omega 3 Fatty Acids in Patients With Chronic Renal Disease

Meta-analyses of the Effect of Important Food Sources of Sugars on Cardiometabolic Risk Factors

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