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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to the tool | Percentage of completed questionnaires | From inclusion and up to 6 months after surgery |
| Number of supportive care and emergency consultations initiated by the caregiver |
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Inclusion Criteria:
Exclusion Criteria:
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 :
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pamela Funk-Debleds, MD | Contact | 0469856020 | +33 | pamela.funk-debleds@lyon.unicancer.fr |
| Clélia Coutzac, MD | Contact | 0469856020 | +33 | clelia.coutzac@lyon.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pamela Funk-Debleds, MD | Centre LĂ©on Berard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre LĂ©on Berard | Recruiting | Lyon | 69008 | France |
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This is a prospective, single-center, single-arm Phase II study.
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|
Number of supportive care and emergency consultations initiated by the caregiver on the bases of questionnaires completed by patients
| From inclusion and up to 6 months after surgery |
| Proportion of patients with malnutrition | Proportion of patients with malnutrition defined according to the criteria of the French National Authority for Health | From inclusion and up to 6 months after surgery |
| Evolution of body composition in L3 section (volumes) | Evolution of body composition based on body composition in L3 section on CT scan in volumes (cm2) at inclusion, after neoadjuvant treatment and 6 months after surgery. | From inclusion and up to 6 months after surgery |
| Evolution of body composition in L3 section (indexes) | Evolution of body composition based on body composition in L3 section on CT scan in indexes (cm2/m2) at inclusion, after neoadjuvant treatment and 6 months after surgery. | From inclusion and up to 6 months after surgery |
| Evolution of resting energy expenditure | Changes in resting energy expenditure (Kcal/day) will be measured at inclusion, at day 5-12 postoperatively, and at 1 month after surgery (before adjuvant treatment) with the measurement of basal metabolic rate quantified by indirect calorimetry (Kcal/day) | From inclusion and up to 1 month after surgery |
| Proportion of patient covering theoretical nutritional requirement >= 30kcal/kg/day | 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. | From inclusion and up to 6 months after surgery |
| Comparison between theoretical nutritional requirement and measurement of basal metabolic rate using indirect calorimetry | 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. | From inclusion and up to 6 months after surgery |
| Weight changes | Weight changes will be described by the weight in kg | From inclusion and up to 6 months after surgery |
| Brachial circumference changes | Brachial circumference will be described in cm | From inclusion and up to 6 months after surgery |
| Triceps skin fold changes | Triceps skin fold will be described in mm | From inclusion and up to 6 months after surgery |
| Initiation time for post-operative treatment | Initiation time for post-operative treatment will be defined as the time in days between the date of surgery and the date of the first course of post operative treatment | From surgery to date of post operative treatment initiation assessed up to 6 months after surgery |
| Proportion of patient with incomplete scheme of pre operative treatment | Proportion of patient with incomplete scheme of pre operative treatment and their causes will be described | From inclusion to surgery |
| Proportion of patient with incomplete scheme of post operative treatment | Proportion of patient with incomplete scheme of post operative treatment and their causes will be described | From surgery and up to 6 months after surgery |
| Proportion of patients with severe post operative complication | 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 | From surgery up to 6 months after surgery |
| Tolerance to perioperative treatment | Tolerance to perioperative treatment will be assessed with self-assessment using myDIET questionnaires and nutritional consultations 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. | From inclusion up to 6 months after surgery |
| Changes in food intake | Changes in food intake will be evaluated during treatment and the postoperative period (myDIET follow-up questionnaires). | From inclusion up to 6 months after surgery |
| Changes in SEFI (Easy Food Intake Score) | Changes in SEFI (Easy Food Intake Score) will be evaluated using visual scales (during treatment and the postoperative period (myDIET follow-up questionnaires). SEFIs are assessed using visual scales ('analogue' or 'portions eaten'). With the visual analogue scale, the patients indicate the quantities they are currently eating using the cursor on the graduated scale from "nothing at all" = 0 to "as usual" = 10. With the visual portions eatenscale , patients can use the cursor to indicate the portions eaten at their last meal (lunch or dinner). | From inclusion up to 6 months after surgery |
| Measurement of quality of life | 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, dyspnoea, insomnia, loss of appetite and constipation); and a global health scale. The score for each item ranges from 1 (not at all) to 4 (very much). | From inclusion and up to 6 months after surgery |
| Average lengh of hospital stay | The average lengh of hospital stay during surgery will be described in terms of the number of days spent in hospital | At the time of surgery |
| Recurrence free survival (RFS) | 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 | From inclusion and up to the date of radiologically documented relapse or death from any cause, whichever came first, assessed up to 30 months |
| Overall survival (OS) | Overall survival (OS) will be defined as the time in days from date of the inclusion to the date of death from any cause | From inclusion and up to the date of death from any cause, assessed up to 30 months |
| Adherence to the physical activity program | Adherence to the physical activity program will be described by the number of weekly session declared by the patient | From inclusion and up to 6 months after surgery |
| Physical activity levels | 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). | From inclusion and up to 6 months after surgery |
| Assessment of muscular function by the 6-min walk test | Assessment of muscular function will be assessed by the 6-min walk test (described in meters) | From inclusion and up to 6 months after surgery |
| Assessment of muscular function by muscular strength | Assessment of muscular function will be assessed by muscular strength measured with hand grip dynamometer (described in kg) | From inclusion and up to 6 months after surgery |
| Assessment of muscular function by the Five Times Sit to Stand Test | Assessment of muscular function will be assessed by the Five Times Sit to Stand Test (described in seconds) | From inclusion and up to 6 months after surgery |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D001519 | Behavior |
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