Clinical trial NCT06385691: Study Evaluating the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer.
Official title: Evaluation of the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Gastric Cancer
Oesogastric Junction Cancer
Keywords: denutrition
software tool
physical activity
postoperative chemotherapy
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, single-center, single-arm Phase II study.
Primary purpose: PREVENTION

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.

Detailed description: Gastric cancer is the 3rd leading cause of cancer mortality worldwide, with a 5-year survival rate of less than 30%. In localised gastric cancer (GC) or cancer of the oesogastric junction (OGJ), the standard treatment consists of gastrectomy and peri-operative FLOT-based chemotherapy (5FU, Leucovorin, Oxaliplatin, Taxotere). However, up to 51% of patients have post-operative complications, and only 60% can benefit from post-operative chemotherapy (at least one course) initiated within 12 weeks of surgery, while 46% receive the full theoretical regimen.

An incomplete adjuvant chemotherapy regimen drastically reduces post-operative prognosis. Undernutrition and sarcopenia increase the occurrence of post-operative complications, length of stay and post-operative readmissions. Undernutrition is an independent risk factor for failure and/or incomplete adjuvant chemotherapy, with an impact on progression-free survival and overall survival. There is a high prevalence of undernutrition in patients with GC/OGJ, estimated at 53-60%, and the proportion of undernourished patients increases significantly postoperatively compared with preoperatively.

Preoperative nutrition and physical activity in sarcopenic patients has been shown to reduce postoperative complications. Early multimodal management, combining nutrition, adapted physical activity and neoadjuvant chemotherapy, is therefore recommended and essential in the perioperative situation. To optimise the nutritional management of patients with operable gastric or oesogastric junction cancer, the CLB teams have developed a computer interface (MyDIET) linked to the myCLB patient portal. This provides semi-personalised monitoring based on self-questionnaires designed to assess and educate patients or their carers about nutritional issues from the outset of oncology treatment, and to prevent the onset or worsening of undernutrition.

For this reason, the sponsor proposes an exploratory study to assess the efficacy of the myDIET digital tool in increasing the proportion of patients with localised CG/OGJ initially treated with neo-adjuvant chemotherapy and who undergo surgery and are able to receive adjuvant chemotherapy within 8 weeks post-operatively.

Eligibility criteria: 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;
* Patient treated with perioperative Oxaliplatin-based chemotherapy,
* 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 (TSH not within laboratory norm at inclusion, usually between 0.4 and 4 mUI/L);
* 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.

Primary outcomes:
measure: Proportion of patients starting adjuvant chemotherapy within 2 months
timeFrame: 2 months after surgery
Secondary outcomes:
measure: Adherence to the tool
timeFrame: From inclusion and up to 6 months after surgery
measure: Number of supportive care and emergency consultations initiated by the caregiver
timeFrame: From inclusion and up to 6 months after surgery
measure: Proportion of patients with malnutrition
timeFrame: From inclusion and up to 6 months after surgery
measure: Evolution of body composition in L3 section (volumes)
timeFrame: From inclusion and up to 6 months after surgery
measure: Evolution of body composition in L3 section (indexes)
timeFrame: From inclusion and up to 6 months after surgery
measure: Evolution of resting energy expenditure
timeFrame: From inclusion and up to 1 month after surgery
measure: Proportion of patient covering theoretical nutritional requirement >= 30kcal/kg/day
timeFrame: From inclusion and up to 6 months after surgery
measure: Comparison between theoretical nutritional requirement and measurement of basal metabolic rate using indirect calorimetry
timeFrame: From inclusion and up to 6 months after surgery
measure: Weight changes
timeFrame: From inclusion and up to 6 months after surgery
measure: Brachial circumference changes
timeFrame: From inclusion and up to 6 months after surgery
measure: Triceps skin fold changes
timeFrame: From inclusion and up to 6 months after surgery
measure: Initiation time for post-operative chemotherapy
timeFrame: From surgery to date of post operative chemotherapy initiation assessed up to 6 months after surgery
measure: Proportion of patient with incomplete scheme of pre operative chemotherapy
timeFrame: From inclusion to surgery
measure: Proportion of patient with incomplete scheme of post operative chemotherapy
timeFrame: From surgery and up to 6 months after surgery
measure: Proportion of patients with severe post operative complication
timeFrame: From surgery up to 6 months ater surgery
measure: Tolerance to perioperative chemotherapy
timeFrame: From inclusion up to 6 months after surgery
measure: Changes in food intake
timeFrame: From inclusion up to 6 months after surgery
measure: Changes in SEFI (Easy Food Intake Score)
timeFrame: From inclusion up to 6 months after surgery
measure: Measurement of quality of life
timeFrame: From inclusion and up to 6 months after surgery
measure: Average lengh of hospital stay
timeFrame: At the time of surgery, an average of 3 months
measure: Recurrence free survival (RFS)
timeFrame: From inclusion and up to the date of radiologically documented relapse or death from any cause, whichever came first, assessed up to 30 months
measure: Overall survival (OS)
timeFrame: From inclusion and up to the date of death from any cause, assessed up to 30 months
measure: Adherence to the physical activity program
timeFrame: From inclusion and up to 6 months after surgery
measure: Physical activity levels
timeFrame: From inclusion and up to 6 months after surgery
measure: Assessment of muscular function by the 6-min walk test
timeFrame: From inclusion and up to 6 months after surgery
measure: Assessment of muscular function by muscular strength
timeFrame: From inclusion and up to 6 months after surgery
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Berard
Study officials:
affiliation: Centre Léon Berard
name: Pamela Funk-Debleds, MD
role: PRINCIPAL_INVESTIGATOR
References: