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

Sponsor

Institut Català d'Oncologia (Other)

Overall Status

Completed

CT.gov ID

NCT02715596

Collaborator

Ferrer Internacional S.A. (Industry)

Enrollment

Location

Arms

44.3

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Squamous Cell Carcinoma of Head and Neck	Dietary Supplement: EPA supplementation Other: Placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

eicosapentanoic acid (EPA) versus placeboeicosapentanoic acid (EPA) versus placebo

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Placebo (EPA)

Primary Purpose:

Supportive Care

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)

Actual Study Start Date :

Dec 23, 2015

Actual Primary Completion Date :

Mar 1, 2019

Actual Study Completion Date :

Sep 2, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention A 2.7 g EPA supplementation in a 15 cc emulsion stick-pack	Dietary Supplement: EPA supplementation 2.7 g EPA supplementation in a 15 cc emulsion stick-pack
Placebo Comparator: Intervention B Placebo supplementation in a 15 cc emulsion stick-pack	Other: Placebo placebo in 15 cc emulsion stick-pack

Arm

Intervention/Treatment

Experimental: Intervention A

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

Dietary Supplement: EPA supplementation

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

Placebo Comparator: Intervention B

Placebo supplementation in a 15 cc emulsion stick-pack

Other: Placebo

placebo in 15 cc emulsion stick-pack

Outcome Measures

Primary Outcome Measures

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]
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.

Secondary Outcome Measures

the effect of supplementation with EPA on muscle mass after induction chemotherapy using imaging such as CT scan [10 weeks]
To evaluate on muscle mass using imaging such as CT scan
Evolution of nutritional status of patients over oncology-specific treatment in both arms. using PG-VGS [1 year]
To assess the evolution of nutritional status using PG-VGS (patient generated subjective global assessment)
The effect of supplementation with EPA regarding acute toxicity during treatment.using the CTCAE v4 criteria [1 year]
To evaluate the frequency of acute toxicity using the CTCAE v4 criteria
The effect of supplementation with EPA in relation to chronic toxicity 2 years after oncologic treatment. (using the CTCAE v4 criteria) [2 years]
To evaluate the frequency of chronic toxicity using the CTCAE v4 criteria
The impact of supplementation with EPA in the loco-regional control at 2 years after completing cancer treatment. [2 years]
To evaluate whether the effect of supplementation with EPA influences the loco-regional control using a CT scan
The effect of supplementation with EPA on the perceptions of patients through quality of life validated questionnaires. [2 year]
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
The adherence to EPA. (using record EPA/placebo dispensing and return and blood samples at baseline and throughout the cancer treatment) [1 year]
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
The functional status of patients throughout the treatment. (functional status using hand grip) [1 year]
To evaluate the functional status using hand grip
The need for nutritional support and nutritional intervention required during cancer treatment among patients supplemented with EPA or placebo. [1 year]
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.
The impact of supplementation with EPA on the recurrence-free survival at 2 years after completing cancer treatment. [2 years]
To evaluate whether the effect of supplementation with EPA influences the recurrence-free survival using a CT scan
The impact of supplementation with EPA on the overall survival at 2 years after completing cancer treatment. [2 years]
To evaluate whether the effect of supplementation with EPA influences the overall survival using a CT scan
The effect of supplementation with EPA on the perceptions of patients through quality of life validated questionnaires. [2 years]
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
The functional status of patients throughout the treatment. (functional status using performance status scale) [1 year]
To evaluate the functional status using performance status scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.