Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06385691
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-04-17
Brief Title:
Study Evaluating the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer
Sponsor:
Centre Leon Berard
Organization:
Centre Leon Berard
Study Overview
Official Title:
Evaluation of the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MyDIET
Brief Summary:
This is a prospective single-center single-arm Phase II study evaluating the efficacy of the myDIET software tool in the nutritional management of patients with localized and resectable esogastric junction cancer
Detailed Description:
Gastric cancer is the 3rd leading cause of cancer mortality worldwide with a 5-year survival rate of less than 30 In localised gastric cancer GC or cancer of the oesogastric junction OGJ the standard treatment consists of gastrectomy and peri-operative FLOT-based chemotherapy 5FU Leucovorin Oxaliplatin Taxotere However up to 51 of patients have post-operative complications and only 60 can benefit from post-operative chemotherapy at least one course initiated within 12 weeks of surgery while 46 receive the full theoretical regimen
An incomplete adjuvant chemotherapy regimen drastically reduces post-operative prognosis Undernutrition and sarcopenia increase the occurrence of post-operative complications length of stay and post-operative readmissions Undernutrition is an independent risk factor for failure andor incomplete adjuvant chemotherapy with an impact on progression-free survival and overall survival There is a high prevalence of undernutrition in patients with GCOGJ estimated at 53-60 and the proportion of undernourished patients increases significantly postoperatively compared with preoperatively
Preoperative nutrition and physical activity in sarcopenic patients has been shown to reduce postoperative complications Early multimodal management combining nutrition adapted physical activity and neoadjuvant chemotherapy is therefore recommended and essential in the perioperative situation To optimise the nutritional management of patients with operable gastric or oesogastric junction cancer the CLB teams have developed a computer interface MyDIET linked to the myCLB patient portal This provides semi-personalised monitoring based on self-questionnaires designed to assess and educate patients or their carers about nutritional issues from the outset of oncology treatment and to prevent the onset or worsening of undernutrition
For this reason the sponsor proposes an exploratory study to assess the efficacy of the myDIET digital tool in increasing the proportion of patients with localised CGOGJ initially treated with neo-adjuvant chemotherapy and who undergo surgery and are able to receive adjuvant chemotherapy within 8 weeks post-operatively
An incomplete adjuvant chemotherapy regimen drastically reduces post-operative prognosis Undernutrition and sarcopenia increase the occurrence of post-operative complications length of stay and post-operative readmissions Undernutrition is an independent risk factor for failure andor incomplete adjuvant chemotherapy with an impact on progression-free survival and overall survival There is a high prevalence of undernutrition in patients with GCOGJ estimated at 53-60 and the proportion of undernourished patients increases significantly postoperatively compared with preoperatively
Preoperative nutrition and physical activity in sarcopenic patients has been shown to reduce postoperative complications Early multimodal management combining nutrition adapted physical activity and neoadjuvant chemotherapy is therefore recommended and essential in the perioperative situation To optimise the nutritional management of patients with operable gastric or oesogastric junction cancer the CLB teams have developed a computer interface MyDIET linked to the myCLB patient portal This provides semi-personalised monitoring based on self-questionnaires designed to assess and educate patients or their carers about nutritional issues from the outset of oncology treatment and to prevent the onset or worsening of undernutrition
For this reason the sponsor proposes an exploratory study to assess the efficacy of the myDIET digital tool in increasing the proportion of patients with localised CGOGJ initially treated with neo-adjuvant chemotherapy and who undergo surgery and are able to receive adjuvant chemotherapy within 8 weeks post-operatively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None