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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Leon Berard

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • myDIET software tool

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: use of myDIET tool for nutritional managementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients starting adjuvant treatment within 2 months

proportion of patients for whom adjuvant treatment could be initiated within 2 months after surgery

Time frame
2 months after surgery

Secondary outcomes

1

Adherence to the tool

Percentage of completed questionnaires

Time frame
From inclusion and up to 6 months after surgery
2

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

Time frame
From inclusion and up to 6 months after surgery
3

Proportion of patients with malnutrition

Proportion of patients with malnutrition defined according to the criteria of the French National Authority for Health

Time frame
From inclusion and up to 6 months after surgery
4

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.

Time frame
From inclusion and up to 6 months after surgery

Other outcomes

Sponsors and contacts

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