Study Evaluating the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer.
- Conditions
- Interventions
- 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
- 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.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description use of myDIET tool for nutritional management myDIET software tool Patients 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
Name Time Method Proportion of patients starting adjuvant chemotherapy within 2 months 2 months after surgery proportion of patients for whom adjuvant chemotherapy could be initiated within 2 months after surgery
- Secondary Outcome Measures
Name Time Method Changes in food intake From 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 chemotherapy From 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 tool From inclusion and up to 6 months after surgery Percentage of completed questionnaires
Weight changes From 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 complication From 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 chemotherapy From 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 stay At 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 program From 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/day From 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 caregiver From 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 malnutrition From 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 calorimetry From 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 changes From inclusion and up to 6 months after surgery Brachial circumference will be described in cm
Triceps skin fold changes From 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 chemotherapy From inclusion to surgery Proportion of patient with incomplete scheme of pre operative chemotherapy and their causes will be described
Measurement of quality of life From 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 levels From 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 expenditure From 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 chemotherapy From 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 strength From 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 test From 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