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Recruiting Phase 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.

NCT06385691 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2024-04-26
Last updated
2026-04-28

Condition(s) studied

Gastric CancerOesogastric Junction Cancer

Investigational drug(s) / intervention(s)

myDIET software tool

myDIET software tool: The tool is based on self-questionnaires completed by the patient. They are mainly filled in using visual analogue scales (from 0-10) or grades of symptoms/toxicities (Grades 0 to 4), based on the CTCAE V5. These scales will cover the following themes: food intake, weight changes, digestive symptoms, taste disorders, pain and fatigue. The system will be able to monitor data changes and the response given will be adapted according to the severity of symptoms: * No signs of seriousness: general prevention or treatment documents/advice: toxicity management, nutritional advices targeted on symptoms, on digestive problems, on appropriate physical activity. * Presence of signs of seriousness: action to be taken and alert to the coordinating nurse, oncologist or dietician. In case of an alert, the coordinating nurse will call the patient back and either manage the symptom, schedule a nutritional consultation to initiate nutritional management, or refer the patient to the oncologist.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Proportion of patients starting adjuvant treatment within 2 months — 2 months after surgery
    proportion of patients for whom adjuvant treatment could be initiated within 2 months after surgery

Trial sites (1)

FacilityCityRegionStatus
Centre Léon Berard Lyon France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06385691 on ClinicalTrials.gov ↗ ← All trials in France