Evaluation of the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of patients starting adjuvant treatment within 2 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •Patients with an indication for perioperative chemotherapy and/or immunotherapy validated in multidisciplinary consultation meeting, with a scheduled surgery date at least 1 month after enrolment;
- •Performance status (ECOG): 0-2;
- •Membership of a social security scheme;
- •Signed informed consent to participate.
排除标准
- •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 :
- •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.
- •Pregnant or breast-feeding patient.
研究组 & 干预措施
use of myDIET tool for nutritional management
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).
干预措施: myDIET software tool (Other)
结局指标
主要结局
Proportion of patients starting adjuvant treatment within 2 months
时间窗: 2 months after surgery
proportion of patients for whom adjuvant treatment could be initiated within 2 months after surgery
次要结局
- Evolution of body composition in L3 section (volumes)(From inclusion and up to 6 months after surgery)
- Proportion of patient covering theoretical nutritional requirement >= 30kcal/kg/day(From inclusion and up to 6 months after surgery)
- Changes in SEFI (Easy Food Intake Score)(From inclusion up to 6 months after surgery)
- Evolution of body composition in L3 section (indexes)(From inclusion and up to 6 months after surgery)
- Evolution of resting energy expenditure(From inclusion and up to 1 month after surgery)
- Changes in food intake(From inclusion up to 6 months after surgery)
- Initiation time for 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(From inclusion to surgery)
- Proportion of patient with incomplete scheme of post operative treatment(From surgery and up to 6 months after surgery)
- Proportion of patients with severe post operative complication(From surgery up to 6 months after surgery)
- Tolerance to perioperative treatment(From inclusion up to 6 months after surgery)
- Average lengh of hospital stay(At the time of surgery)
- Assessment of muscular function by the Five Times Sit to Stand Test(From inclusion and up to 6 months after surgery)
- Adherence to the tool(From inclusion and up to 6 months after surgery)
- Weight changes(From inclusion and up to 6 months after surgery)
- Adherence to the physical activity program(From inclusion and up to 6 months after surgery)
- Number of supportive care and emergency consultations initiated by the caregiver(From inclusion and up to 6 months after surgery)
- Proportion of patients with malnutrition(From inclusion and up to 6 months after surgery)
- Comparison between theoretical nutritional requirement and measurement of basal metabolic rate using indirect calorimetry(From inclusion and up to 6 months after surgery)
- Brachial circumference changes(From inclusion and up to 6 months after surgery)
- Triceps skin fold changes(From inclusion and up to 6 months after surgery)
- Measurement of quality of life(From inclusion and up to 6 months after surgery)
- 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)
- Physical activity levels(From inclusion and up to 6 months after surgery)
- Overall survival (OS)(From inclusion and up to the date of death from any cause, assessed up to 30 months)
- Assessment of muscular function by muscular strength(From inclusion and up to 6 months after surgery)
- Assessment of muscular function by the 6-min walk test(From inclusion and up to 6 months after surgery)