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

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Trial Identification

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

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

Study ID: NCT06149546

Interventions

Control
Intervention

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

St Vincent's University Hospital, Dublin, Leinster, Ireland

Contact Details

Name: Oonagh Griffin, Dr

Affiliation: SVUH/University College Dublin

Role: PRINCIPAL_INVESTIGATOR

Name: Ray McDermott, Prof

Affiliation: St Vincent's University Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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