AzTrials
AzTrials

Squamous Cell Carcinoma of Head and NeckPhase 3hepaneckNCT02715596

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

A Phase 3 study testing EPA supplementation in people with Squamous Cell Carcinoma of Head and Neck, run by Institut Català d'Oncologia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Carcinoma of Head and Neck
What is being tested?
EPA supplementation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
1 siteSpain
Study dates
23 Dec 2015to 2 Sep 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • - 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.
Show all 11Show fewer
  • 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

Who cannot join

  • - 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Institut Catala d'Oncologia- L'Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

Other trials in Spain

About this study

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)

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

Read the 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.

Being tested
EPA supplementation, Placebo
Keywords
head and neck, eicosapentanoic acid, body composition
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EPA supplementationDietary supplement

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

  • PlaceboOther

    placebo in 15 cc emulsion stick-pack

Study groups in NCT02715596
Study groupRoleWhat they receive
Intervention AExperimental2.7 g EPA supplementation in a 15 cc emulsion stick-pack
Receives: Dietary Supplement: EPA supplementation
Intervention BPlacebo comparatorPlacebo supplementation in a 15 cc emulsion stick-pack
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 years

Secondary outcomes (13)

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

    To evaluate on muscle mass using imaging such as CT scan

    Measured: 10 weeks

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

    To assess the evolution of nutritional status using PG-VGS (patient generated subjective global assessment)

    Measured: 1 year

  3. The effect of supplementation with EPA regarding acute toxicity during treatment.using the CTCAE v4 criteria

    To evaluate the frequency of acute toxicity using the CTCAE v4 criteria

    Measured: 1 year

  4. The effect of supplementation with EPA in relation to chronic toxicity 2 years after oncologic treatment. (using the CTCAE v4 criteria)

    To evaluate the frequency of chronic toxicity using the CTCAE v4 criteria

    Measured: 2 years

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

    To evaluate whether the effect of supplementation with EPA influences the loco-regional control using a CT scan

    Measured: 2 years

  6. The effect of supplementation with EPA on the perceptions of patients through quality of life validated questionnaires.

    • 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

    Measured: 2 year

  7. The adherence to EPA. (using record EPA/placebo dispensing and return and blood samples at baseline and throughout the cancer treatment)

    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

    Measured: 1 year

  8. The functional status of patients throughout the treatment. (functional status using hand grip)

    To evaluate the functional status using hand grip

    Measured: 1 year

  9. The need for nutritional support and nutritional intervention required during cancer treatment among patients supplemented with EPA or placebo.

    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.

    Measured: 1 year

  10. The impact of supplementation with EPA on the recurrence-free survival at 2 years after completing cancer treatment.

    To evaluate whether the effect of supplementation with EPA influences the recurrence-free survival using a CT scan

    Measured: 2 years

  11. The impact of supplementation with EPA on the overall survival at 2 years after completing cancer treatment.

    To evaluate whether the effect of supplementation with EPA influences the overall survival using a CT scan

    Measured: 2 years

  12. The effect of supplementation with EPA on the perceptions of patients through quality of life validated questionnaires.

    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

    Measured: 2 years

  13. The functional status of patients throughout the treatment. (functional status using performance status scale)

    To evaluate the functional status using performance status scale

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2016 (estimated)
  2. Study start23 Dec 2015
  3. Primary completion1 Mar 2019
  4. Study completion2 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
eicosapentanoic acid (EPA) versus placebo
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02715596
Sponsor's protocol ID
PR 261/14
Acronym
hepaneck
Status last verified
Sep 2019
First submitted
12 Feb 2015
Last updated
4 Sep 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Publications

  • Arribas L, Hurtos L, Esteve A, Peiro I, Gonzalez-Tampan AR, Choulli M, Antonio M, Vilajosana E, Borbalas AL, Taberna M, Mesia R. Nutritional impact of eicosapentaenoic acid supplementation (EPA) in patients with locally advanced head and neck cancer: a double-blind placebo-controlled randomized trial. Nutr J. 2025 Sep 26;24(1):140. doi: 10.1186/s12937-025-01203-8.

    PubMed 41013487

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EPA supplementation in people with Squamous Cell Carcinoma of Head and Neck, run by Institut Català d'Oncologia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02715596, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in