Multi-centric, Placebo-controlled Trial of Omega-3 Fatty Acid Supplementation in Weight Maintenance and Preservation of Lean Body Mass, in (Pre)Cachectic Head and Neck Cancer Patients, Undergoing Curative Radio(Chemo)Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 4
- 主要终点
- prevention of therapy-related weight loss
研究概览
简要总结
Cancer cachexia is a complex metabolic process affecting up to 80% of patients suffering from an advanced-stage cancer. Moreover, 20 to 40% of all cancer deaths are caused directly by cachexia. Head and neck (H&N) cancer patients are nutritionally vulnerable since tumour localisation can interfere with food intake, since alcohol and tobacco abuse - two etiological risk factors of H&N cancer - are associated with nutritional deficits, and since the intensive treatment can lead to progressive weight loss. Recently, omega-3 fatty acids have gained interest for their beneficial effects in several diseases. Moreover, nutritional supplementation enriched with omega-3 FA could potentially maintain body weight in cancer patients undergoing intensive treatment.
Aims In this study, the investigators want to evaluate the use of omega-3 FA supplementation as nutritional and the investigators would like to identify potential risk factors, biomarkers and objective measurement tools which can predict therapy-induced cachexia.
详细描述
Design A prospective, placebo-controlled trial. H&N cancer patients eligible for curative treatment will be randomised to receive standard nutritional support with placebo (15ml/day Sunflower oil, control group) or nutritional support with omega-3 FA supplementation (15ml/day Echium oil, experimental group) during radio(chemo)therapy. All patients will undergo a nutritional screening (Patient-Generated Subjective Global Assessment), a quality of life evaluation (EORTC QLQ C30 & HN35) and will be asked to keep a 3-day food diary at the start of their therapy, and again during the 4th week and the end of therapy. Body composition and grip strength will be measured with bio-electrical impedance (BIA) analysis, Dual X-ray absorptiometry (DXA) and the JAMAR® hydraulic hand dynamometer once at baseline, and again in the 4th week of therapy. Blood samples are collected at baseline, and in the 4th week of therapy to (1) verify compliance rate by measuring fatty acid concentration, (2) verify the presence of potential biomarkers that can predict cachexia and (3) to detect the presence of SNPs associated with severe acute dysphagia. Demographic data, tumour characteristics and therapy-related toxicity will also be collected.
Population Newly diagnosed non-metastatic (stage I-IVB) head and neck cancer patients (≥18 or older) eligible for curative primary or adjuvant radiotherapy with or without systemic therapy
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)
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
- •Histologically confirmed squamous cell carcinoma of the head and neck region, generally cancer of the oral cavity, (naso)pharynx and larynx. Cancer of the parotid gland, or nasal cavity and paranasal sinuses are excluded, as well as cT1 N0 M0 tumours of the glottis.
- •Primary cancer or relapse, eligible for primary or adjuvant radiotherapy with or without systemic treatment, with curative intent
- •TNM stage I to IVB, without distant metastases
- •Patients should be older than 18 at the time of enrolment
- •Patients should be able to adequately communicate in Dutch or French
排除标准
- •Patients younger than 18 years at the time of recruitment
- •Pregnant or lactating women
- •Patients presenting with another non-cured cancer (PSA or CEA not within normal range as determined by the treating physician)
- •Patients that already underwent a radio(chemo)therapy treatment within the last 6 months
- •Patients taking oral anticoagulants or LMWH at therapeutic doses
- •Patients taking anti-epileptics
- •Patients with an indication of heart failure NYHA 3 or 4, or presence of an implantable cardioverter-defibrillator
- •Patients with a pacemaker will be excluded from BIA-analysis
- •Patients presenting with active intestinal co-morbidity, precluding adequate dietary intake or interfering with the absorption of the nutritional supplements (eg Crohn's disease)
- •Patients with a known eating disorder (eg anorexia nervosa, bulimia nervosa)
- •Patients with uncontrollable diabetes
- •HIV-positive patients
- •Patients with (severe) dementia (DSM-IV criteria)
- •Patients actively taking fish oil, echium oil or omega-3 FA supplements in the last 4 weeks before enrolment
结局指标
主要结局
prevention of therapy-related weight loss
时间窗: 7 weeks
difference between body weight at baseline and end of therapy
次要结局
- determination of beneficial (and possible side) effects of omega-3 FA supplements in general, and specifically on body weight and body composition(7 weeks)
- establish feasibility, variability and distribution of BIA, DXA and JAMAR® as objective measurement tools of body composition(7 weeks)
- identification of potential clinical risk factors of cachexia(7 weeks)
- evaluation of the use and reliability of different validated nutritional screening tools in this population(7 weeks)
- identification and evaluation of potential biomarkers for therapy-induced cachexia(7 weeks)
- measurement of difference in quality of life(7 weeks)
- dropout and compliance to nutritional supplements(7 weeks)
研究者
Dr. Philip Debruyne
Consultant Medical Oncologist
General Hospital Groeninge