RecruitingPhase 2NCT06385691

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

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


Sponsor

Centre Leon Berard

Enrollment

60 participants

Start Date

Apr 26, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This French study is testing a digital nutrition tool called myDIET to help patients with resectable stomach or gastro-esophageal junction cancer maintain their nutritional health during perioperative chemotherapy (chemotherapy given both before and after surgery). **You may be eligible if...** - You are 18 or older - You have been diagnosed with stomach or esophagogastric junction adenocarcinoma that can be surgically removed - You are receiving oxaliplatin-based chemotherapy - You are in generally reasonable health (ECOG 0–2) - You (or your caregiver) can access and use the myDIET software **You may NOT be eligible if...** - You have another active cancer - You have severe other health conditions or an uncontrolled thyroid problem - You have had previous stomach, duodenum, or esophagus surgery - You have difficulty understanding written French - You are already enrolled in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERmyDIET 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.


Locations(1)

Centre Léon Berard

Lyon, France

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NCT06385691


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