Effects of Dietary Supplementation With omega3-fatty Acids (Fish Oil) and Progressive Resistance Training on Skeletal Muscle Status in Gynaecological, Gastrointestinal and Urological Cancer Patients (SUPPORT)
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
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.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Bavaria
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Erlangen、Bavaria、德国、91056
- 招聘中
- Hector-Center for Nutrition, Exercise and Sports
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接触：
- Prof. Dr. med. Yurdagül Zopf
- 电话号码：0049091318545220
- 邮箱：yurdaguel.zopf@uk-erlangen.de
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：Placebo, no training
Placebo (corn oli) and no training program
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4x capsueles daily
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安慰剂比较：Placebo, training group
Placebo (corn oli) and 2x weekly resistance training
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4x capsueles daily
2x weekly resistance training
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实验性的：Omega-3, no training
Verum (Omega-3-capsules with fish oil) and no training program
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4x capsules containing 500 mg EPA and 250 mg DHA
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实验性的：Omega-3, training group
Verum (Omega-3-capsules with fish oil) and 2x weekly resistance training
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2x weekly resistance training
4x capsules containing 500 mg EPA and 250 mg DHA
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Skeletal Muscle Status I
大体时间：Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Body composition: BIA (SMM in kg)
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Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Skeletal Muscle Status II
大体时间：Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Muscle function: Tensiomyography (TMG) (Dm in mm, Tc in ms, Td in ms, Ts in ms, Tr in ms)
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Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Skeletal Muscle Status III
大体时间：Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Maximal muscle strength: estimated one-repetition maximum (1-RM in kg)
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Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Skeletal Muscle Status IV
大体时间：Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Handgrip strength: dynamometer (in kg)
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Baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
|
Physical Performance I
大体时间：baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Functional exercise capacity: 6-minute walk test (distance in m)
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baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Physical Performance II
大体时间：baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Daily physical activity: International Physical Activity Questionnaire (IPAQ)
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baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
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Physical Performance III
大体时间：baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Accelerometry over 7 consecutive days (steps)
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baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Nutritional Status I
大体时间：baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
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Malnutrition screening: Nutritional Risk Screening Score (NRS 2002) [0 (no risk) - 7 (highest risk)]
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baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
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Nutritional Status II
大体时间：baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
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Dietary intake and nutrient analysis: 3 or 7-day dietary record for assessment of energy and protein intake (in g)
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baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
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Nutritional Status III
大体时间：baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
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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)
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baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, 6 months follow-up after study completion
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient-Reported Outcomes I
大体时间：baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Appetite perception: VAS-scale (Visual Analog Scale 0 [none] - 10 [excessive])
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baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
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Patient-Reported Outcomes II
大体时间：baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
Quality of life: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)
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baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Patient-Reported Outcomes III
大体时间：baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Fatigue: The Functional Assessment of Chronic Illness Therapy (FACIT) - Scale [0-52, higher scores indicate better quality of life and less severe fatigue]
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baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
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Patient-Reported Outcomes III
大体时间：baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Symptom burden and treatment-related side effects: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
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baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Patient-Reported Outcomes IV
大体时间：baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Edmonton Symptom Assessment Scale (ESAS) [0 (none) - 10 (worst possible)]
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baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Omega-3-Index
大体时间：baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
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Laboratory Endpoints: Omega-3 Fatty Acid Status as Blood-Based Biomarkers
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baseline, 6 weeks, 12 weeks, 6 months follow-up after study completion
|
合作者和调查者
调查人员
- 学习椅：Yurdagül Zopf, Prof. Dr. med.、Universitätsklinikum Erlangen
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- SUPPORT-Study
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