Evaluating a software tool for nutritional management in gastric cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre Léon Berard
  Lyon, France Recruiting

Study contacts

• Principal investigator: Pamela Funk-Debleds, MD — Centre Léon Berard
• Study coordinator: Pamela Funk-Debleds, MD
• Email: pamela.funk-debleds@lyon.unicancer.fr
• Phone: 0469856020

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.