An interventional study of Control and Intervention in Pancreatic Cancer, sponsored by Cancer Trials Ireland. Recruiting at 1 site in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-08.
Sponsored by Cancer Trials Ireland · Not applicable, Interventional, and Supportive care
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.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
This study's planned enrollment of 70 is above the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Cancer Trials Ireland is the lead sponsor of 71 studies on the registry; 8 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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
Dietary Supplement: Control
* 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
Dietary Supplement: Intervention
* 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
Effectiveness 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
Plan to share: Yes — Pseudo-anonymised data will be shared with research partner University College of Dublin for performance of the study.
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: Study duration
Access criteria: IPD data will be shared for all patients who provide informed consent to participation in the study
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