Exploring the Impact of a Multi-modal Nutritional Intervention in Patients Undergoing Chemotherapy for Pancreatic Cancer (FEED Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Effectiveness of a multi-modal nutrition-led intervention in preventing loss of muscle strength (hand-grip strength) during chemotherapy
研究概览
简要总结
The study will examine if a multi-modal nutritional care package, with or without resistance training delivered with neoadjuvant chemotherapy, is effective at preventing loss of muscle strength during neoadjuvant chemotherapy for pancreatic cancer. There are two arms in this study: Control Arm will receive standard dietetic care and be prescribed standard pancreatic enzyme replacement therapy and oral nutritional supplement drinks with their neoadjuvant chemotherapy. The intervention Arm will have 3 additional dietitian visits and 6 physiotherapist visits that the control group will not.
详细描述
This is a translational, single-site, open-label, randomised, prospective 12-week study. 70 (35 in each arm) patients will be enrolled in the study; The study will examine if a multi-modal nutritional care package, with or without resistance training delivered concurrently to neoadjuvant chemotherapy, is effective at preventing loss of muscle strength during neoadjuvant chemotherapy for pancreatic cancer. There are two arms in this study: The control group will receive standard dietetic care and be prescribed standard pancreatic enzyme replacement therapy and oral nutritional supplement drinks concurrently with their neoadjuvant chemotherapy. The intervention group in comparison to the control group will have 3 additional dietitian visits and 6 physiotherapist visits that the control group will not.
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
- None
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
- •Ability to give signed informed consent and willing and able to comply with the protocol.
- •Patients aged 18 years and above.
- •Patients with newly diagnosed, pathologically confirmed pancreatic ductal adenocarcinoma who will undergo neoadjuvant chemotherapy following formal MDT assessment at St Vincent's University Hospital, specifically FOLFIRINOX or Gemcitabine with Nab-Paclitaxel (and/or any additional therapy regimen approved by NCCP).
- •Patients have CT scan available and suitable for body composition analysis within 8 weeks prior to randomisation.
- •Patients have adequate upper limb dexterity to allow assessment of hand grip strength.
排除标准
- •Patients who are unable to consume oral diet and require prolonged enteral and/or parenteral nutritional support.
- •Patient with any significant history of non-compliance to medical treatments or with inability to grant reliable informed consent.
- •Patients who can/will not consume fish and pork products due to allergy, intolerance, religious beliefs, or dietary preferences.
- •Patients with known blood clotting disorders, e.g antiphospholipid syndrome, factor V Leiden syndrome, haemophilia /any liver disease which has progressed to liver cirrhosis where prolonged fish oil supplementation is unsafe.
- •Patients with uncontrolled hypertension (BP >180/110 mm Hg) which prohibits exercise.
- •Patients with muscle wasting disorders, e.g. paraplegia, motor neuron disease, Duchenne muscular dystrophy, multiple sclerosis.
- •Women who are pregnant or breastfeeding due to differing nutritional needs and macronutrient metabolism.
结局指标
主要结局
Effectiveness of a multi-modal nutrition-led intervention in preventing loss of muscle strength (hand-grip strength) during chemotherapy
时间窗: 12 weeks
To compare the effectiveness of a multi-modal nutrition-led intervention in preventing loss of muscle strength (Percentage change in handgrip strength as determined by handgrip dynamometry) during chemotherapy with an intensive multi-modal nutrition and physiotherapist delivered intervention (1:1 randomisation).
次要结局
- Effectiveness of the intervention compared to the control on Overall Survival(6 months)
- Effectiveness of the intervention compared to the control on weight changes(12 weeks)
- To compare the effectiveness of the intervention compared to the control on patient acceptance/adherence.(12 weeks)
- Patient health-related quality of life (change in EORTC QLQ-C30 function or symptom score)(12 weeks)
- Change in Timed-up and Go (seconds) between control and intervention cohorts.(12 weeks)
- To compare the effectiveness of the intervention compared to the control on treatment delivery(6 months)
- Changes in lumbar skeletal muscle index between control and intervention cohorts.(6 months)
- Changes in inflammatory markers and cytokine levels between control and intervention cohorts.(12 weeks)
- To compare the effectiveness of the intervention compared to the control on treatment response(6 months)
- Changes in skeletal muscle between control and intervention cohorts.(6 months)
- Effectiveness of the intervention compared to the control on body composition indices(6 months)