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 | Recruiting Phase 2

• 1 other identifier: ET22-145
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer; Oesogastric Junction Cancer

Keywords

denutrition; software tool; physical activity; postoperative treatment; chemotherapy; immunotherapy

Outcome Measures

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

  2 months after surgery

Secondary Outcomes (27)

• Adherence to the tool

  From inclusion and up to 6 months after surgery

• Number of supportive care and emergency consultations initiated by the caregiver

  From inclusion and up to 6 months after surgery

• Proportion of patients with malnutrition

  From inclusion and up to 6 months after surgery

• Evolution of body composition in L3 section (volumes)

  From inclusion and up to 6 months after surgery

• Evolution of body composition in L3 section (indexes)

  From inclusion and up to 6 months after surgery

Study Arms (1)

use of myDIET tool for nutritional management

EXPERIMENTAL

Patients will be followed up at regular intervals during neoadjuvant treatment, perioperatively and up to 6 months after the date of surgery (after completion of postoperative treatment).

Other: myDIET software tool

Interventions

myDIET software tool OTHER

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.

use of myDIET tool for nutritional management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Léon Berard

Lyon, 69008, France

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Behavior

Study Officials

• Pamela Funk-Debleds, MD

  Centre Léon Berard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela Funk-Debleds, MD

CONTACT

0469856020; pamela.funk-debleds@lyon.unicancer.fr

Clélia Coutzac, MD

CONTACT

0469856020; clelia.coutzac@lyon.unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-center, single-arm Phase II study.

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 26, 2024
• Study Start: April 26, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

FR (1)