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NCT Number: NCT06385691

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • 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.

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 :
  • 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.

Treatment and study plan

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:

  • 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.

Primary outcomes

  1. Proportion of patients starting adjuvant treatment within 2 months

    Time frame: 2 months after surgery

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

Secondary outcomes

  1. Adherence to the tool

    Time frame: From inclusion and up to 6 months after surgery

    Percentage of completed questionnaires

  2. Number of supportive care and emergency consultations initiated by the caregiver

    Time frame: 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

  3. Proportion of patients with malnutrition

    Time frame: 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

  4. Evolution of body composition in L3 section (volumes)

    Time frame: 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 treatment and 6 months after surgery.

  5. Evolution of body composition in L3 section (indexes)

    Time frame: 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 treatment and 6 months after surgery.

  6. Evolution of resting energy expenditure

    Time frame: From inclusion and up to 1 month after surgery

    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)

  7. Proportion of patient covering theoretical nutritional requirement >= 30kcal/kg/day

    Time frame: 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.

  8. Comparison between theoretical nutritional requirement and measurement of basal metabolic rate using indirect calorimetry

    Time frame: 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.

  9. Weight changes

    Time frame: From inclusion and up to 6 months after surgery

    Weight changes will be described by the weight in kg

  10. Brachial circumference changes

    Time frame: From inclusion and up to 6 months after surgery

    Brachial circumference will be described in cm

  11. Triceps skin fold changes

    Time frame: From inclusion and up to 6 months after surgery

    Triceps skin fold will be described in mm

  12. Initiation time for post-operative treatment

    Time frame: From surgery to date of post operative treatment initiation assessed up to 6 months after surgery

    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

  13. Proportion of patient with incomplete scheme of pre operative treatment

    Time frame: From inclusion to surgery

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

  14. Proportion of patient with incomplete scheme of post operative treatment

    Time frame: From surgery and up to 6 months after surgery

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

  15. Proportion of patients with severe post operative complication

    Time frame: From surgery up to 6 months after 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

  16. Tolerance to perioperative treatment

    Time frame: From inclusion up to 6 months after surgery

    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.

  17. Changes in food intake

    Time frame: From inclusion up to 6 months after surgery

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

  18. Changes in SEFI (Easy Food Intake Score)

    Time frame: From inclusion up to 6 months after surgery

    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).

  19. Measurement of quality of life

    Time frame: 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, 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).

  20. Average lengh of hospital stay

    Time frame: At the time of surgery

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

  21. Recurrence free survival (RFS)

    Time frame: 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

  22. Overall survival (OS)

    Time frame: 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

  23. Adherence to the physical activity program

    Time frame: 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

  24. Physical activity levels

    Time frame: 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).

  25. Assessment of muscular function by the 6-min walk test

    Time frame: 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)

  26. Assessment of muscular function by muscular strength

    Time frame: 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)

  27. Assessment of muscular function by the Five Times Sit to Stand Test

    Time frame: From inclusion and up to 6 months after surgery

    Assessment of muscular function will be assessed by the Five Times Sit to Stand Test (described in seconds)

Study contacts

Contact information is provided by the study sponsor or research team.

Clélia Coutzac, MD

CONTACT

[email protected]

0469856020 ext. +33

Pamela Funk-Debleds, MD

CONTACT

[email protected]

0469856020 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Official study title

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

Acronym: MyDIET

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 26, 2024
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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