Enteral Omega 3 During Radiotherapy to Improve the Quality of Life and Functionality of Head and Neck Cancer Patients
Anahtar kelimeler
Öz
Açıklama
- Objective: To determine the effect of the daily addition of five mL of an O3 highly concentrated substance (EicosaPentaenoic Acid - EPA: 2.25 g and DocosaHexaenoic Acid - DHA: 1.08 g), to the standard enteral nutrition diet during RT (5-7 weeks), on the Quality of Life (QoL) and Functionality (Fx) of patients with HNSCC.
- Methods: Randomized, double-blinded, controlled clinical trial. Patients with HNSCC (ages ranging from 18-80 years) who will receive total enteral nutrition support through percutaneous endoscopic gastrostomy and RT for the first time will be invited to participate in the study. Exclusion criteria are fish allergy, anticoagulant consumption, any supplement consumption 6 months prior to the experiment, any contraindication to the performance of the body composition analysis using bioelectrical impedance (Bioelectrical Impedance Analysis, BIA) (cardiac pacemaker, any metallic prosthesis, inability to stand, severe edema), or the presence of the mal-absorption syndrome, two or more cancer types, organ dysfunction, immune diseases, or any hospitalization during the 20 days prior to extraction of the blood sample. Patients with the consumption of any other nutritional supplement or diagnosed with any other cancer during the treatment period, or with insufficient or incorrectly processed blood-serum samples will be eliminated. After expressing their willingness to participate via the signing of the informed consent document, 86 patients with HNSCC will be allocated into two groups: The O3 Group will have the addition of 5 mL of an O3 highly concentrated substance containing 2.25 g of EPA and 1.08 g of DHA to the standard enteral diet during RT (5-7 weeks), and the Placebo or Control Group will have the addition of 5 mL of a placebo (pigmented and flavored corn oil) in a similar manner. All patients will be seen every 4 weeks at the Nutrition Support Service for nutritional assessment and counseling, and to receive the enteral nutrition containers (standard polymeric diet). On the same day, a Research Assistant (who will be blinded) will provide the supplements or the placebo. The patients' sociodemographic and clinical information, body composition, albumin, hemoglobin, C-reactive protein, tumor cachexia-related cytokines: IL (Interleukin) 1a, IL-1b, IL-6, IL-8, IFNγ (Interferon gamma), TGF-β (transforming growth factor beta), and TNF-α (Tumor necrosis factor alpha); and responses for the European Organisation for Research and Treatment of Cancer Quality of Life C-30 (EORTC-QLQ-C30) with the Head and Neck Cancer module (EORTC-QLQ-H&N35) questionnaires will be collected at the beginning of RT, at the end of RT, and 12 weeks after starting RT. Statistical analysis includes descriptive statistics, inference statistics (Student t-test, Mann-Whitney test, one-way ANOVA with Bonferroni correction, Kruskal-Wallis with Dunn's non-parametric test), and the Cox regression; an intention-to-treat analysis will be performed.
Tarih
Son Doğrulandı: | 06/30/2020 |
İlk Gönderilen: | 10/14/2018 |
Tahmini Kayıt Gönderildi: | 10/23/2018 |
İlk Gönderilen: | 10/24/2018 |
Son Güncelleme Gönderildi: | 07/13/2020 |
Son Güncelleme Gönderildi: | 07/14/2020 |
Fiili Çalışma Başlangıç Tarihi: | 10/09/2018 |
Tahmini Birincil Tamamlanma Tarihi: | 12/30/2021 |
Tahmini Çalışma Tamamlanma Tarihi: | 12/30/2021 |
Durum veya hastalık
Müdahale / tedavi
Dietary Supplement: Omega 3 Group
Dietary Supplement: Placebo or Control Group
Evre
Kol Grupları
Kol | Müdahale / tedavi |
---|---|
Experimental: Omega 3 Group Five mL of an Omega-3 highly concentrated substance (containing 2.25 g of EPA and 1.08 g of DHA) will be added daily to the standard enteral diet during the entire radiotherapy treatment period (from 5-7 weeks) | Dietary Supplement: Omega 3 Group Five mL of an Omega-3 highly concentrated substance (containing 2.25 g of EPA and 1.08 g of DHA) will be added daily to the standard enteral diet during the entire radiotherapy |
Placebo Comparator: Placebo or Control Group Five mL of pigmented and flavored corn oil will be added daily to the standard enteral diet during the entire radiotherapy treatment period (from 5-7 weeks) | Dietary Supplement: Placebo or Control Group Five mL of pigmented and flavored corn oil will be added daily to the standard enteral diet during the entire radiotherapy treatment period (from 5-7 weeks) |
Uygunluk kriterleri
Çalışmaya Uygun Yaşlar | 18 Years İçin 18 Years |
Çalışmaya Uygun Cinsiyetler | All |
Sağlıklı Gönüllüleri Kabul Ediyor | Evet |
Kriterler | Inclusion Criteria: - Head and Neck Squamous Cell Carcinoma (HNSCC) confirmed by histologic - Eligible for receiving total enteral nutrition support through percutaneous endoscopic gastrostomy for the first time - Eligible for receiving RadioTherapy (RT) for the first time Exclusion Criteria: - Allergy to fish - Consumption of anticoagulants - Consumption of any supplement 6 months prior to the experiment - Any contraindication to the performance of the Bioelectrical Impedance Analysis (BIA) (cardiac pacemaker, any metallic prosthesis, inability to stand, severe edema) - Mal-absorption syndrome - Two or more cancer types - Organ dysfunction - Immune diseases - Any hospitalization during the 20 days prior to extraction of the blood sample |
Sonuç
Birincil Sonuç Ölçütleri
1. Change in Global Health Status/Quality of Life (GHS/QoL) subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) [From baseline (time 0) up to the ending of RT (from 5-7 weeks) (time 1); from baseline up to 12 weeks (time 2)]
2. Change in Physical Functioning (PF) subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) [From baseline (time 0) up to the ending of RT (from 5-7 weeks) (time 1); from baseline up to 12 weeks (time 2)]
İkincil Sonuç Ölçütleri
1. Changes in serum cancer cachexia-related cytokines: IL (Interleukin)-1a, IL-1b, IL-6, IL-8, IFNγ (Interferon gamma), TGF-β (transforming growth factor beta), and TNF-α (Tumor necrosis factor alpha) [From baseline (time 0) up to the ending of RT (from 5-7 weeks) (time 1); from baseline up to 12 weeks (time 2)]