Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06385691
Other study ID # ET22-145
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date April 29, 2024
Est. completion date August 31, 2026

Study information

Verified date April 2024
Source Centre Leon Berard
Contact Pamela Funk-Debleds, MD
Phone 0469856020
Email pamela.funk-debleds@lyon.unicancer.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date August 31, 2026
Est. primary completion date June 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
myDIET software tool
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: No signs of seriousness: general prevention or treatment documents/advice: toxicity management, nutritional advices targeted on symptoms, on digestive problems, on appropriate physical activity. Presence of signs of seriousness: action to be taken and alert to the coordinating nurse, oncologist or dietician. 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.

Locations

Country Name City State
France Centre Léon Berard Lyon

Sponsors (1)

Lead Sponsor Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients starting adjuvant chemotherapy within 2 months proportion of patients for whom adjuvant chemotherapy could be initiated within 2 months after surgery 2 months after surgery
Secondary Adherence to the tool Percentage of completed questionnaires From inclusion and up to 6 months after surgery
Secondary Number of supportive care and emergency consultations initiated by the caregiver 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
Secondary 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
Secondary 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 chemotherapy and 6 months after surgery. From inclusion and up to 6 months after surgery
Secondary 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 chemotherapy and 6 months after surgery. From inclusion and up to 6 months after surgery
Secondary Evolution of resting energy expenditure 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) From inclusion and up to 1 month after surgery
Secondary 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
Secondary 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
Secondary Weight changes Weight changes will be described by the weight in kg From inclusion and up to 6 months after surgery
Secondary Brachial circumference changes Brachial circumference will be described in cm From inclusion and up to 6 months after surgery
Secondary Triceps skin fold changes Triceps skin fold will be described in mm From inclusion and up to 6 months after surgery
Secondary Initiation time for post-operative chemotherapy 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 From surgery to date of post operative chemotherapy initiation assessed up to 6 months after surgery
Secondary Proportion of patient with incomplete scheme of pre operative chemotherapy Proportion of patient with incomplete scheme of pre operative chemotherapy and their causes will be described From inclusion to surgery
Secondary Proportion of patient with incomplete scheme of post operative chemotherapy Proportion of patient with incomplete scheme of post operative chemotherapy and their causes will be described From surgery and up to 6 months after surgery
Secondary 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 ater surgery
Secondary Tolerance to perioperative chemotherapy 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.
From inclusion up to 6 months after surgery
Secondary Changes in food intake Changes in food intake will be evaluated during chemotherapy and the postoperative period (myDIET follow-up questionnaires). From inclusion up to 6 months after surgery
Secondary Changes in SEFI (Easy Food Intake Score) Changes in SEFI (Easy Food Intake Score) will be evaluated using visual scales (during chemotherapy 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
Secondary 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
Secondary 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, an average of 3 months
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05551416 - The EpiGASTRIC/EDGAR Project: New Strategies for the Early Detection and Prevention of Gastric Cancer
Completed NCT05518929 - Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients Phase 4
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03219593 - Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer Phase 2
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT05536102 - The Effectiveness and Safety of XELOX and Tislelizumab + PLD for Resectable Gastric Cancer (LidingStudy) Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Recruiting NCT05415098 - Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas Phase 1
Active, not recruiting NCT04082364 - Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer Phase 2/Phase 3
Withdrawn NCT03766607 - Trastuzumab Beyond Progression in HER2 Positive Metastatic Gastric Cancer Phase 2
Recruiting NCT04118114 - Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors Phase 2
Completed NCT01924533 - Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer. Phase 3
Terminated NCT01641939 - A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer Phase 2/Phase 3
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Active, not recruiting NCT04908813 - Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer Phase 2
Active, not recruiting NCT04249739 - Pembrolizumab + Capecitabine/Oxaliplatin (CapeOx) -HER2 Nagative and Pembrolizumab + Trastuzumab + Cisplatin/Capecitabine HER2 Positive Phase 2
Recruiting NCT05514158 - To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Disitamab Vedotin Combined With RC98 in the Treatment of Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer (Including AEG) Phase 1
Recruiting NCT04931654 - A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer Phase 1/Phase 2
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2