Study Evaluating the Efficacy of the myDIET Software Tool in the Nutritional Management of Patien… (NCT06385691) | Clinical Trial Compass
RecruitingPhase 2
Study Evaluating the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer.
France60 participantsStarted 2024-04-26
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Proportion of patients starting adjuvant treatment within 2 months