Evaluating a software tool for nutritional management in gastric cancer patients

Evaluation of the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer.

This study is testing a new software tool to help people with stomach cancer manage their nutrition better to see if it can improve their recovery and quality of life.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Leon Berard (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Lyon)
• Trial ID: NCT06385691 on ClinicalTrials.gov

What this trial studies

This Phase II interventional study assesses the efficacy of the myDIET software tool in managing nutrition for patients with localized and resectable gastric or esogastric junction cancer. The study aims to address the high prevalence of undernutrition and its impact on postoperative complications and chemotherapy outcomes. By integrating nutrition and physical activity into the perioperative care of these patients, the study seeks to improve their overall survival and quality of life. Participants will be monitored for their nutritional status and adherence to the software tool throughout their treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with localized, resectable gastric adenocarcinoma or esogastric junction cancer who are undergoing perioperative chemotherapy.

Not a fit: Patients with severe comorbidities, other associated cancers, or those unable to comply with the study requirements may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance the nutritional management of gastric cancer patients, potentially improving their treatment outcomes and survival rates.

How similar studies have performed: While the specific use of the myDIET software tool is novel, similar multimodal approaches combining nutrition and physical activity have shown promise in improving outcomes for surgical cancer patients.

Eligibility criteria

Inclusion Criteria:

* Patient 18 years of age or older at date of signing informed consent to participate;
* Histologically proven diagnosis of gastric adenocarcinoma or OGJ;
* Localized, resectable disease;
* Patients with an indication for perioperative chemotherapy and/or immunotherapy validated in multidisciplinary consultation meeting, with a scheduled surgery date at least 1 month after enrolment;
* Performance status (ECOG): 0-2;
* Membership of a social security scheme;
* Signed informed consent to participate.

Exclusion Criteria:

* Other associated solid cancer or haemopathy;
* Presence of severe comorbidity (Charlson index \> 9)
* Presence of unbalanced dysthyroidism;
* History of gastric, duodenal or esophageal surgery;
* Inability to comply with study requirements, including :

  * Impossibility for the patient or his/her caregiver to connect to myDIET;
  * Difficulty in understanding the written French language;
  * Psychological incapacity (e.g. excessive vulnerability, psychiatric disorder) or physical incapacity (e.g. physical/motor disability);
* Patient under guardianship, curatorship or safeguard of justice;
* Patients already participating in a clinical trial or interventional study likely to interfere with the evaluation of the primary endpoint.
* Pregnant or breast-feeding patient.

Where this trial is running

Lyon

• Centre Léon Berard — Lyon, France (Recruiting)

Study contacts

• Principal investigator: Pamela Funk-Debleds, MD — Centre Léon Berard
• Study coordinator: Pamela Funk-Debleds, MD

Conditions Gastric Cancer; Oesogastric Junction Cancer; denutrition; software tool; physical activity; postoperative treatment; chemotherapy; immunotherapy