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

Registration Number
NCT06385691
Lead Sponsor
Centre Leon Berard
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 ha...

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
60
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
use of myDIET tool for nutritional managementmyDIET software toolPatients will be followed up at regular intervals during neoadjuvant chemotherapy, perioperatively and up to 6 months after the date of surgery (after completion of postoperative chemotherapy).
Primary Outcome Measures
NameTimeMethod
Proportion of patients starting adjuvant chemotherapy within 2 months2 months after surgery

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

Secondary Outcome Measures
NameTimeMethod
Changes in food intakeFrom inclusion up to 6 months after surgery

Changes in food intake will be evaluated during chemotherapy and the postoperative period (myDIET follow-up questionnaires).

Initiation time for post-operative chemotherapyFrom surgery to date of post operative chemotherapy initiation assessed up to 6 months after surgery

Initiation time for post-operative chemotherapy will be defined as the time in days between the date of surgery and the date of the first course of post operative chemotherapy

Evolution of body composition in L3 section (volumes)From inclusion and up to 6 months after surgery

Evolution of body composition based on body composition in L3 section on CT scan in volumes (cm2) at inclusion, after neoadjuvant chemotherapy and 6 months after surgery.

Adherence to the toolFrom inclusion and up to 6 months after surgery

Percentage of completed questionnaires

Weight changesFrom inclusion and up to 6 months after surgery

Weight changes will be described by the weight in kg

Proportion of patients with severe post operative complicationFrom surgery up to 6 months ater surgery

Proportion of patients with severe post operative complication will be described according to the occurence of a grade \> III complication according to Clavien Dindo classification

Tolerance to perioperative chemotherapyFrom inclusion up to 6 months after surgery

Tolerance to perioperative chemotherapy will be assessed with self-assessment using myDIET questionnaires based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5 classification.

Grades range from 1 to 5 and refer to the severity of the adverse event. A higher grade means a worse outcome.

Average lengh of hospital stayAt the time of surgery, an average of 3 months

The average lengh of hospital stay during surgery will be described in terms of the number of days spent in hospital

Adherence to the physical activity programFrom inclusion and up to 6 months after surgery

Adherence to the physical activity program will be described by the number of weekly session declared by the patient

Proportion of patient covering theoretical nutritional requirement >= 30kcal/kg/dayFrom inclusion and up to 6 months after surgery

The proportion of patients with dietary intakes \> or equal to 30kcal/kg/day will be quantified during the dietary consultation at inclusion, at day 7 after surgery, at 1 month after surgery and 6 months after surgery.

Changes in SEFI (Easy Food Intake Score)From inclusion up to 6 months after surgery

Changes in SEFI (Easy Food Intake Score) will be evaluated using visual scales (during chemotherapy and the postoperative period (myDIET follow-up questionnaires).
...

Number of supportive care and emergency consultations initiated by the caregiverFrom inclusion and up to 6 months after surgery

Number of supportive care and emergency consultations initiated by the caregiver on the bases of questionnaires completed by patients

Proportion of patients with malnutritionFrom inclusion and up to 6 months after surgery

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

Comparison between theoretical nutritional requirement and measurement of basal metabolic rate using indirect calorimetryFrom inclusion and up to 6 months after surgery

Theoretical nutritional requirement and measurement of basal metabolic rate using indirect calorimetry (kcal/day) will be quantified during the dietary consultation at inclusion, at day 7 after surgery, at 1 month after surgery and 6 months after surgery.

Brachial circumference changesFrom inclusion and up to 6 months after surgery

Brachial circumference will be described in cm

Triceps skin fold changesFrom inclusion and up to 6 months after surgery

Triceps skin fold will be described in mm

Proportion of patient with incomplete scheme of pre operative chemotherapyFrom inclusion to surgery

Proportion of patient with incomplete scheme of pre operative chemotherapy and their causes will be described

Measurement of quality of lifeFrom inclusion and up to 6 months after surgery

Quality of life will be assessed with European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This 30-item questionnaire is completed by the patient and includes five multi-item functional scales (physical, role, cognitive, emotional and social); eight symptom scales (fatigue, pain, nausea and vomiting, dyspn...

Recurrence free survival (RFS)From inclusion and up to the date of radiologically documented relapse or death from any cause, whichever came first, assessed up to 30 months

Recurrence free survival (RFS) will be definied as the duration in days between the date of inclusion and the date of radiologically documented relapse or death from any cause

Physical activity levelsFrom inclusion and up to 6 months after surgery

Physical activity levels will be assessed using the International Physical Activity Questionnaire (short version). The questions ask how much time the patient has spent being physically active over the last 7 days (duration of activity in minutes or hours, and number of days of activity in days).

Evolution of body composition in L3 section (indexes)From inclusion and up to 6 months after surgery

Evolution of body composition based on body composition in L3 section on CT scan in indexes (cm2/m2) at inclusion, after neoadjuvant chemotherapy and 6 months after surgery.

Evolution of resting energy expenditureFrom inclusion and up to 1 month after surgery

Changes in resting energy expenditure (Kcal/day) will be measured at inclusion, at day 7 postoperatively, and at 1 month after surgery (before adjuvant chemotherapy) with the measurement of basal metabolic rate quantified by indirect calorimetry (Kcal/day)

Proportion of patient with incomplete scheme of post operative chemotherapyFrom surgery and up to 6 months after surgery

Proportion of patient with incomplete scheme of post operative chemotherapy and their causes will be described

Overall survival (OS)From inclusion and up to the date of death from any cause, assessed up to 30 months

Overall survival (OS) will be defined as the time in days from date of the inclusion to the date of death from any cause

Assessment of muscular function by muscular strengthFrom inclusion and up to 6 months after surgery

Assessment of muscular function will be assessed by muscular strength measured with hand grip dynamometer (described in kg)

Assessment of muscular function by the 6-min walk testFrom inclusion and up to 6 months after surgery

Assessment of muscular function will be assessed by the 6-min walk test (described in meters)

Trial Locations

Locations (1)

Centre Léon Berard

🇫🇷

Lyon, France

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