SUPPORT-Study = Effects of a Dietary SUPPlementation With Omega3-fatty Acids/ Fish Oil and Progressive Resistence Training on Skeletal Muscle Status in Gynaecological, Gastrointestinal, and Urological Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Skeletal Muscle Status I
研究概览
简要总结
Cancer cachexia is a common and prognostically relevant complication of advanced malignancies, characterized by systemic inflammation, increased catabolism, and reduced nutritional intake, leading to a progressive loss of skeletal muscle mass, physical performance, and quality of life. Muscle wasting negatively affects the tolerability and efficacy of oncological therapies and exacerbates distressing symptoms such as fatigue. Consequently, international guidelines recommend combined nutritional and exercise interventions as key components of supportive cancer care. However, due to treatment-related limitations, conventional exercise programs are often difficult to implement, highlighting the need for feasible, time-efficient, and individually adaptable training concepts suitable for daily life.
In addition, adequate protein-rich nutrition is essential and may be supported by targeted nutritional supplementation. Omega-3 fatty acids, particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), have demonstrated anti-inflammatory effects and beneficial influences on nutritional status, quality of life, and potentially skeletal muscle mass.
The aim of the present project is to investigate, in a randomized, placebo-controlled trial, whether the combination of progressive resistance training (twice-weekly TheraBand-based exercise) and omega-3 supplementation (daily intake of 2 g EPA and 1 g DHA administered as fish oil capsules) can improve muscle status, physical performance, and patient-relevant outcomes such as quality of life, appetite, and fatigue in cancer patients at high risk of developing cancer cachexia.
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
- Double (Participant, Outcomes Assessor)
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
- •Patients with malignant tumors undergoing curative or palliative treatment, including breast, ovarian, esophageal, pancreatic, gastric, colon, rectal, and prostate cancer, across all UICC stages
- •Women and men aged 18 years or older
- •ECOG performance status 0-2
排除标准
- •Patients younger than 18 years
- •Bone metastases or skeletal involvement associated with a high risk of fracture
- •Pregnant or breastfeeding women
- •Patients with psychiatric disorders that raise concerns regarding decision-making capacity or ability to provide informed consent
- •Participation in other exercise and/or nutritional intervention studies within the previous 3 months
- •Current use of fish oil supplements
- •Severe cardiovascular disease, NYHA class IV
研究组 & 干预措施
Placebo, no training
Placebo (corn oli) and no training program
干预措施: Corn Oil Placebo, 4 capsules/day for 12 weeks (Dietary Supplement)
Placebo, training group
Placebo (corn oli) and 2x weekly resistance training
干预措施: Training (Behavioral)
Placebo, training group
Placebo (corn oli) and 2x weekly resistance training
干预措施: Corn Oil Placebo, 4 capsules/day for 12 weeks (Dietary Supplement)
Omega-3, no training
Verum (Omega-3-capsules with fish oil) and no training program
干预措施: Omega 3 FA (Fish Oil) (Dietary Supplement)
Omega-3, training group
Verum (Omega-3-capsules with fish oil) and 2x weekly resistance training
干预措施: Omega 3 FA (Fish Oil) (Dietary Supplement)
Omega-3, training group
Verum (Omega-3-capsules with fish oil) and 2x weekly resistance training
干预措施: Training (Behavioral)
结局指标
主要结局
Skeletal Muscle Status I
时间窗: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Body composition: BIA (SMM in kg)
Skeletal Muscle Status II
时间窗: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Muscle function: Tensiomyography (TMG) (Dm in mm, Tc in ms, Td in ms, Ts in ms, Tr in ms)
Skeletal Muscle Status III
时间窗: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Maximal muscle strength: estimated one-repetition maximum (1-RM in kg)
Skeletal Muscle Status IV
时间窗: Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Handgrip strength: dynamometer (in kg)
Physical Performance I
时间窗: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Functional exercise capacity: 6-minute walk test (distance in m)
Physical Performance II
时间窗: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Daily physical activity: International Physical Activity Questionnaire (IPAQ)
Physical Performance III
时间窗: baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
Accelerometry over 7 consecutive days (steps)
Nutritional Status I
时间窗: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
Malnutrition screening: Nutritional Risk Screening Score (NRS 2002) \[0 (no risk) - 7 (highest risk)\]
Nutritional Status II
时间窗: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
Dietary intake and nutrient analysis: 3 or 7-day dietary record for assessment of energy and protein intake (in g)
Nutritional Status III
时间窗: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
Dietary intake and nutrient analysis: 3 or 7-day dietary record and assessment of consumption of EPA- and DHA-rich foods, and omega-3/omega-6 fatty acid ratio (in g)
次要结局
- Patient-Reported Outcomes I(baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion)
- Patient-Reported Outcomes II(baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion)
- Patient-Reported Outcomes III(baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion)
- Patient-Reported Outcomes IV(baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion)
- Omega-3-Index(baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion)