Clinical trial NCT02715596: Changes in Body Composition After EPA Supplementation in Head and Neck Patients
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Squamous Cell Carcinoma of Head and Neck
Keywords: head and neck
eicosapentanoic acid
body composition
Lead sponsor: Institut Català d'Oncologia
Sponsor class: OTHER
Collaborators: name: Ferrer Internacional S.A.
First posted: 2016-03-22
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: eicosapentanoic acid (EPA) versus placebo
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 3 years
Secondary outcomes:
measure: the effect of supplementation with EPA on muscle mass after induction chemotherapy using imaging such as CT scan
timeFrame: 10 weeks
measure: Evolution of nutritional status of patients over oncology-specific treatment in both arms. using PG-VGS
timeFrame: 1 year
measure: The effect of supplementation with EPA regarding acute toxicity during treatment.using the CTCAE v4 criteria
timeFrame: 1 year
measure: The effect of supplementation with EPA in relation to chronic toxicity 2 years after oncologic treatment. (using the CTCAE v4 criteria)
timeFrame: 2 years
measure: The impact of supplementation with EPA in the loco-regional control at 2 years after completing cancer treatment.
timeFrame: 2 years
measure: The effect of supplementation with EPA on the perceptions of patients through quality of life validated questionnaires.
timeFrame: 2 year
measure: The adherence to EPA. (using record EPA/placebo dispensing and return and blood samples at baseline and throughout the cancer treatment)
timeFrame: 1 year
measure: The functional status of patients throughout the treatment. (functional status using hand grip)
timeFrame: 1 year
measure: The need for nutritional support and nutritional intervention required during cancer treatment among patients supplemented with EPA or placebo.
timeFrame: 1 year
measure: The impact of supplementation with EPA on the recurrence-free survival at 2 years after completing cancer treatment.
timeFrame: 2 years
measure: The impact of supplementation with EPA on the overall survival at 2 years after completing cancer treatment.
timeFrame: 2 years
measure: The effect of supplementation with EPA on the perceptions of patients through quality of life validated questionnaires.
timeFrame: 2 years
measure: The functional status of patients throughout the treatment. (functional status using performance status scale)
timeFrame: 1 year
Other outcomes:
Locations:
city: L´hospitalet de Llobregat
country: Spain
facility: Institut Catala d'Oncologia- L'Hospitalet
state: Barcelona
Study officials:
affiliation: Institut Català d'Oncologia
name: Lorena Arribas, RD, MsC
role: PRINCIPAL_INVESTIGATOR
References: