Exploring the Impact of a Multi-modal Nutritional Intervention in Patients Undergoing Chemotherapy for Pancreatic Cancer (FEED Trial)

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Control
  * High protein, high energy diet * Fish oil supplement (ProSure®) * Pancreatic Enzymes (Creon®) * A daily individualised step target (10% above your own baseline) * Four scheduled appointments with a dietitian
• Пищевая добавка Intervention
  * High protein, high energy diet * Fish oil supplement (ProSure®) * Pancreatic Enzymes (Creon®) * A daily individualised step target (10% above your own baseline) * Seven scheduled appointments with a dietitian * Six scheduled appointments with a physiotherapist

Первичные конечные точки

• Effectiveness of a multi-modal nutrition-led intervention in preventing loss of muscle strength (hand-grip strength) during chemotherapy [Срок оценки: 12 weeks]

Вторичные конечные точки (12)

• Effectiveness of the intervention compared to the control on weight changes [Срок оценки: 12 weeks]
• To compare the effectiveness of the intervention compared to the control on treatment delivery [Срок оценки: 6 months]
• To compare the effectiveness of the intervention compared to the control on treatment delivery [Срок оценки: 6 months]
• To compare the effectiveness of the intervention compared to the control on treatment delivery [Срок оценки: 6 months]
• To compare the effectiveness of the intervention compared to the control on treatment response [Срок оценки: 6 months]
• To compare the effectiveness of the intervention compared to the control on treatment response [Срок оценки: 6 months]
• To compare the effectiveness of the intervention compared to the control on patient acceptance/adherence. [Срок оценки: 12 weeks]
• Patient health-related quality of life (change in EORTC QLQ-C30 function or symptom score) [Срок оценки: 12 weeks]
• Change in Timed-up and Go (seconds) between control and intervention cohorts. [Срок оценки: 12 weeks]
• Changes in inflammatory markers and cytokine levels between control and intervention cohorts. [Срок оценки: 12 weeks]
• Changes in inflammatory markers and cytokine levels between control and intervention cohorts. [Срок оценки: 12 weeks]
• Changes in inflammatory markers and cytokine levels between control and intervention cohorts. [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Ирландия · 1 центр

• St Vincent's University Hospital — Dublin

Идентификаторы

NCT: NCT06149546 · CTRIAL-IE 20-26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗