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Trial Title:
Study Evaluating the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer.
NCT ID:
NCT06385691
Condition:
Gastric Cancer
Oesogastric Junction Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
denutrition
software tool
physical activity
postoperative chemotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This is a prospective, single-center, single-arm Phase II study.
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
myDIET software tool
Description:
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.
Arm group label:
use of myDIET tool for nutritional management
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 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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Léon Berard
Address:
City:
Lyon
Zip:
69008
Country:
France
Status:
Recruiting
Contact:
Last name:
Pamela Funk-Debleds, MD
Phone:
0469856020
Phone ext:
+33
Email:
pamela.funk-debleds@lyon.unicancer.fr
Contact backup:
Last name:
Clélia Coutzac, MD
Phone:
0469856020
Phone ext:
+33
Email:
clelia.coutzac@lyon.unicancer.fr
Start date:
April 26, 2024
Completion date:
August 31, 2026
Lead sponsor:
Agency:
Centre Leon Berard
Agency class:
Other
Source:
Centre Leon Berard
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06385691
