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

NCT02715596 | Completed Phase 3

• 1 other identifier: PR 261/14
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Conditions

Squamous Cell Carcinoma of Head and Neck

Keywords

head and neck; eicosapentanoic acid; body composition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• the effect of supplementation with EPA on muscle mass after induction chemotherapy using imaging such as CT scan

  10 weeks

• Evolution of nutritional status of patients over oncology-specific treatment in both arms. using PG-VGS

  1 year

• The effect of supplementation with EPA regarding acute toxicity during treatment.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)

  2 years

• The impact of supplementation with EPA in the loco-regional control at 2 years after completing cancer treatment.

  2 years

Study Arms (2)

Intervention A

EXPERIMENTAL

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

Dietary Supplement: EPA supplementation

Intervention B

PLACEBO COMPARATOR

Placebo supplementation in a 15 cc emulsion stick-pack

Other: Placebo

Interventions

EPA supplementation DIETARY_SUPPLEMENT

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

Intervention A

Placebo OTHER

placebo in 15 cc emulsion stick-pack

Intervention B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Age between 18 and 75 years inclusive.
• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Institut Català d'Oncologia: lead
• Ferrer Internacional S.A.: collaborator

Study Sites (1)

Institut Catala d'Oncologia- L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Lorena Arribas, RD, MsC

  Institut Català d'Oncologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Placebo (EPA)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: eicosapentanoic acid (EPA) versus placebo

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: March 22, 2016
• Study Start: December 23, 2015
• Primary Completion: March 1, 2019
• Study Completion: September 2, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)