Changes in Body Composition After EPA Supplementation in Head and Neck Patients

Study Overview
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Brief Summary
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Evaluates the effect of EPA supplementation in terms of muscle mass in patients with squamous cell carcinoma of the head and neck locally advanced

Detailed Description
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This study is designed to evaluate the effect of EPA supplementation on muscle mass in patients with squamous cell carcinoma of the head and neck locally advanced (stage III-IVb) to assess that supplementation with EPA can maintain muscle mass along the oncologic treatment. Other aims are to evaluate the nutritional status, acute and chronic toxicities related with the loss of muscle mass and the impact of the EPA supplementation on overall and disease-free survival.

Official Title
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Relationship Between Changes in Body Composition and Supplementation With EPA in Patients Diagnosed With Squamous Cell Carcinoma of Head and Neck Locally Advanced (Stage III-IVb)

Conditions
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Squamous Cell Carcinoma of Head and Neck

Intervention / Treatment
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* Dietary Supplement: EPA supplementation
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Age between 18 and 75 years inclusive. A performance status 0-1 according to ECOG (Eastern Cooperative Oncology Group) scale at the time of inclusion in the study. Expectancy greater than 3 months life. Location: oral cavity, oropharynx, larynx,hypopharynx, nasopharynx and sinuses. Patients with squamous cell carcinoma of the head and neck classified as locally advanced (Stage III, IVa-IVb). Patients with medical conditions to receive neoadjuvant chemotherapy (CT) induction followed by radiotherapy (RDT) normo fraction combined with QT or biological. Neutrophil ≥1500 / mm3, platelet count ≥150,000 / mm3 and hemoglobin ≥10g / dL. Adequate liver function: total bilirubin ≤ 1 x ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN; Alkaline phosphatase (ALP) ≤ 5 x ULN. Serum albumin-adjusted calcium ≤ 1.25 x upper limit of normal (ULN). Using an effective contraceptive method for patients of both sexes where the risk of conception and / or pregnancy. Signature of written informed consent before any study-specific procedures Exclusion Criteria: - Metastatic disease (stage IVc). Surgery, radiotherapy and / or chemotherapy prior to study disease treatment. T3 N0-1 larynx. Other stadiums than III or IV without distant metastases and stable disease. Another synchronous squamous carcinoma. Diagnosis of other malignancy within the past 5 years, except in situ of the cervix and / or adequately treated basal cell carcinoma skin cancer. Active infection (infection requiring intravenous antibiotic), including active tuberculosis and HIV diagnosed. Uncontrolled hypertension defined as systolic blood pressure ≥180mm Hg and / or diastolic blood pressure≥ 130 mm Hg at rest. Pregnancy (absence must be confirmed with β-HCG (Human chorionic gonadotropin) serum test) or lactating. Systemic, chronic immune and concomitant treatment, or hormonal treatment of cancer. Other concomitant antineoplastic treatment. Clinically significant coronary artery or a history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled heart failure. Chronic obstructive pulmonary disease that would have required ≥3 hospitalizations in the last 12 months. Uncontrolled active peptic ulcer. Presence of a psychological or medical illness that prevented the study by the patient or to grant the signature on the informed consent. Abuse of known drugs (with the exception of heavy drinking). Allergic reaction known against any component of study treatment. Previous treatment with monoclonal antibodies or other inhibitors of signal transduction or treatment directed against the EGFR (epidermal growth factor receptor). Any experimental therapy within 30 days prior to study entry.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: eicosapentanoic acid (EPA) versus placebo
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention A<br>2.7 g EPA supplementation in a 15 cc emulsion stick-pack | Dietary Supplement: EPA supplementation<br>* 2.7 g EPA supplementation in a 15 cc emulsion stick-pack<br>|
| Placebo Comparator: Intervention B<br>Placebo supplementation in a 15 cc emulsion stick-pack | Other: Placebo<br>* placebo in 15 cc emulsion stick-pack<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of supplementation with EPA on muscle mass during a conservative non-surgical treatment of organ in patients with squamous cell carcinoma of head and neck locally advanced. | To evaluate the effect of supplementation with EPA on muscle mass during a conservative non-surgical treatment of organ in patients with squamous cell carcinoma of head and neck locally advanced. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effect of supplementation with EPA on muscle mass after induction chemotherapy using imaging such as CT scan | To evaluate on muscle mass using imaging such as CT scan | 10 weeks | 
| Evolution of nutritional status of patients over oncology-specific treatment in both arms. using PG-VGS | To assess the evolution of nutritional status using PG-VGS (patient generated subjective global assessment) | 1 year | 
| The effect of supplementation with EPA regarding acute toxicity during treatment.using the CTCAE v4 criteria | To evaluate the frequency of acute toxicity using the CTCAE v4 criteria | 1 year | 
| The effect of supplementation with EPA in relation to chronic toxicity 2 years after oncologic treatment. (using the CTCAE v4 criteria) | To evaluate the frequency of chronic toxicity using the CTCAE v4 criteria | 2 years | 
| The impact of supplementation with EPA in the loco-regional control at 2 years after completing cancer treatment. | To evaluate whether the effect of supplementation with EPA influences the loco-regional control using a CT scan | 2 years | 
| The effect of supplementation with EPA on the perceptions of patients through quality of life validated questionnaires. | o To evaluate and compare the effect of supplementation with EPA on the perceptions of patients through quality of life questionnaires (QLQ) validated such as QLA-C30 | 2 year | 
| The adherence to EPA. (using record EPA/placebo dispensing and return and blood samples at baseline and throughout the cancer treatment) | To assess adherence to EPA using record EPA/placebo dispensing and return and blood samples at baseline and throughout the cancer treatment of the EPA concentration in the erythrocyte membrane | 1 year | 
| The functional status of patients throughout the treatment. (functional status using hand grip) | To evaluate the functional status using hand grip | 1 year | 
| The need for nutritional support and nutritional intervention required during cancer treatment among patients supplemented with EPA or placebo. | To compare the need for nutritional support and nutritional intervention required using data collection sheet with the different types of nutritional support, days of each nutritional intervention and adherence to it. | 1 year | 
| The impact of supplementation with EPA on the recurrence-free survival at 2 years after completing cancer treatment. | To evaluate whether the effect of supplementation with EPA influences the recurrence-free survival using a CT scan | 2 years | 
| The impact of supplementation with EPA on the overall survival at 2 years after completing cancer treatment. | To evaluate whether the effect of supplementation with EPA influences the overall survival using a CT scan | 2 years | 
| The effect of supplementation with EPA on the perceptions of patients through quality of life validated questionnaires. | To evaluate and compare the effect of supplementation with EPA on the perceptions of patients through quality of life questionnaires (QLQ) validated such as QLQ-H&N35 | 2 years | 
| The functional status of patients throughout the treatment. (functional status using performance status scale) | To evaluate the functional status using performance status scale | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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head and neck, eicosapentanoic acid, body composition