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

NCT ID: NCT02715596

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-23
• Study Completion Date: 2019-09-02

Brief Summary

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

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.

Conditions

Squamous Cell Carcinoma of Head and Neck

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Intervention A

2.7 g EPA supplementation in a 15 cc emulsion stick-pack

Group Type: EXPERIMENTAL

EPA supplementation

Intervention Type: DIETARY_SUPPLEMENT

2.7 g EPA supplementation in a 15 cc emulsion stick-pack

Intervention B

Placebo supplementation in a 15 cc emulsion stick-pack

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

placebo in 15 cc emulsion stick-pack

Interventions

EPA supplementation

2.7 g EPA supplementation in a 15 cc emulsion stick-pack

Intervention Type: DIETARY_SUPPLEMENT

Placebo

placebo in 15 cc emulsion stick-pack

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferrer Internacional S.A.

INDUSTRY

Sponsor Role: collaborator

Institut Català d'Oncologia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorena Arribas, RD, MsC

Role: PRINCIPAL_INVESTIGATOR

Institut Català d'Oncologia

Locations

Institut Catala d'Oncologia- L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Countries

Spain

Other Identifiers

PR 261/14

Identifier Type: -

Identifier Source: org_study_id