Changes in Body Composition After EPA Supplementation in Head and Neck Patients (hepaneck)

Institut Català d'Oncologia

Status and phase

Completed

Phase 3

Conditions

Squamous Cell Carcinoma of Head and Neck

Treatments

Dietary Supplement: EPA supplementation

Other: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02715596

PR 261/14

Details and patient eligibility

About

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

Full 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.

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.