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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
70
* 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
* 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
St Vincent's University Hospital
Dublin, Leinster, Ireland
RECRUITINGEffectiveness of a multi-modal nutrition-led intervention in preventing loss of muscle strength (hand-grip strength) during chemotherapy
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).
Time frame: 12 weeks
Effectiveness of the intervention compared to the control on weight changes
To compare the effectiveness of a multi-modal nutrition-led intervention on weight changes (kg and %) versus the control.
Time frame: 12 weeks
To compare the effectiveness of the intervention compared to the control on treatment delivery
Treatment delivery will be defined based on the occurrence of dose limiting toxicity (NCI CTCAE grading V5).
Time frame: 6 months
To compare the effectiveness of the intervention compared to the control on treatment delivery
Treatment delivery will be defined based on the need for dose reduction due to weight loss.
Time frame: 6 months
To compare the effectiveness of the intervention compared to the control on treatment delivery
Treatment delivery will be defined based on unplanned hospital admissions (frequency, duration (days), reason).
Time frame: 6 months
To compare the effectiveness of the intervention compared to the control on treatment response
Treatment response will be assessed by Resectability Status per National Cancer Control Network (NCCN)
Time frame: 6 months
To compare the effectiveness of the intervention compared to the control on treatment response
Treatment response will be assessed by Radiographic Classification of Borderline Resectable Pancreatic Cancer
Time frame: 6 months
To compare the effectiveness of the intervention compared to the control on patient acceptance/adherence.
Patient acceptance/adherence is defined as attendance at dietetic and physiotherapy appointments, dose of ONS and PERT delivered vs prescribed, step target achievement, exercise program adherence and progress.
Time frame: 12 weeks
Patient health-related quality of life (change in EORTC QLQ-C30 function or symptom score)
To compare the effectiveness of a multi-modal nutrition-led intervention on patient health-related quality of life (change in European Organisation for Research and Treatment of Cancer - Core Quality of Life questionnaire (EORTC QLQ-C30) function or symptom score) versus the control. The core EORTC QLQ C30 questionnaire has five functioning subscale scores and nine symptoms subscale scores. Minimum value = 0; Max value = 100 Function Scales: Higher numbers mean better function Symptom Scale: Higher numbers mean more symptoms
Time frame: 12 weeks
Change in Timed-up and Go (seconds) between control and intervention cohorts.
To compare the effectiveness of a multi-modal nutrition-led intervention on function (change in Timed-up and Go (seconds)) versus the control.
Time frame: 12 weeks
Changes in inflammatory markers and cytokine levels between control and intervention cohorts.
Changes in C-reactive Protein (CRP) will be measured between control and intervention cohorts.
Time frame: 12 weeks
Changes in inflammatory markers and cytokine levels between control and intervention cohorts.
Changes in Tumour Necrosis Factor-alpha (TNF-α) will be measured between control and intervention cohorts.
Time frame: 12 weeks
Changes in inflammatory markers and cytokine levels between control and intervention cohorts.
Changes in Interleukin-6 (IL-6) will be measured between control and intervention cohorts.
Time frame: 12 weeks
Changes in lumbar skeletal muscle index between control and intervention cohorts.
To compare the effectiveness of a multi-modal nutrition-led intervention on lumbar skeletal muscle index (cm²/m²) via diagnostic and restaging CT scans.
Time frame: 6 months
Changes in skeletal muscle between control and intervention cohorts.
To compare the effectiveness of a multi-modal nutrition-led intervention on skeletal muscle (area in cm²) via diagnostic and restaging CT scans
Time frame: 6 months
Changes in skeletal muscle between control and intervention cohorts.
To compare the effectiveness of a multi-modal nutrition-led intervention on skeletal muscle (mass in kg) via diagnostic and restaging CT scans
Time frame: 6 months
Effectiveness of the intervention compared to the control on body composition indices
To compare the effectiveness of a multi-modal nutrition-led intervention on lumbar adipose tissue (area in cm²) via diagnostic and restaging CT scans.
Time frame: 6 months
Effectiveness of the intervention compared to the control on body composition indices
To compare the effectiveness of a multi-modal nutrition-led intervention on lumbar adipose tissue (mass in kg) via diagnostic and restaging CT scans.
Time frame: 6 months
Effectiveness of the intervention compared to the control on body composition indices
To compare the effectiveness of a multi-modal nutrition-led intervention on body composition indices: assessment of muscle attenuation (Hounsfield Units (HU)) via diagnostic and restaging CT scans.
Time frame: 6 months
Effectiveness of the intervention compared to the control on Overall Survival
Overall survival rate at 6 months following the first day of chemotherapy and median overall survival time.
Time frame: 6 months
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