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临床试验/NCT02715596
NCT02715596已完成3 期

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)

Institut Català d'Oncologia2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2015年12月23日最近更新:
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适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
54
试验地点
2
主要终点
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.
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

Placebo (EPA)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •- 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

排除标准

  • •- 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.

研究组 & 干预措施

Intervention A

Experimental

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

干预措施: EPA supplementation (Dietary Supplement)

Intervention B

Placebo Comparator

Placebo supplementation in a 15 cc emulsion stick-pack

干预措施: Placebo (Other)

结局指标

主要结局

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.

时间窗: 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.

次要结局

  • the effect of supplementation with EPA on muscle mass after induction chemotherapy using imaging such as CT scan(10 weeks)
  • The impact of supplementation with EPA in the loco-regional control at 2 years after completing cancer treatment.(2 years)
  • The need for nutritional support and nutritional intervention required during cancer treatment among patients supplemented with EPA or placebo.(1 year)
  • 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 functional status of patients throughout the treatment. (functional status using hand grip)(1 year)
  • The impact of supplementation with EPA on the recurrence-free survival at 2 years after completing cancer treatment.(2 years)
  • The effect of supplementation with EPA on the perceptions of patients through quality of life validated questionnaires.(2 years)
  • The adherence to EPA. (using record EPA/placebo dispensing and return and blood samples at baseline and throughout the cancer treatment)(1 year)
  • The impact of supplementation with EPA on the overall survival at 2 years after completing cancer treatment.(2 years)
  • The functional status of patients throughout the treatment. (functional status using performance status scale)(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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