About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Other associated solid cancer or haemopathy;
Presence of severe comorbidity (Charlson index > 9)
Presence of unbalanced dysthyroidism;
History of gastric, duodenal or esophageal surgery;
Trial design
Single group
Treatments tested in this trial
myDIET software tool
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Proportion of patients starting adjuvant treatment within 2 months
proportion of patients for whom adjuvant treatment could be initiated within 2 months after surgery
Secondary outcomes
Adherence to the tool
Percentage of completed questionnaires
Number of supportive care and emergency consultations initiated by the caregiver
Number of supportive care and emergency consultations initiated by the caregiver on the bases of questionnaires completed by patients
Proportion of patients with malnutrition
Proportion of patients with malnutrition defined according to the criteria of the French National Authority for Health
Evolution of body composition in L3 section (volumes)
Evolution of body composition based on body composition in L3 section on CT scan in volumes (cm2) at inclusion, after neoadjuvant treatment and 6 months after surgery.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.