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Patients with advanced gastrointestinal (GI) cancers are very often sarcopenic/malnourished at diagnosis (> 60% of cases) and at high risk of rapid clinical deterioration. These patients have important supportive care needs that represent a major challenge for improving treatment tolerance and patient survival and health-related quality of life (HRQoL).
Malnutrition and sarcopenia (muscle wasting and dysfunction) are associated with an increased risk of death, complications from chemotherapy, infections, emergency procedures and hospitalizations, and increased costs of care. Therefore, malnutrition and sarcopenia represent a major clinical target in GI cancers.
Interventions targeting malnutrition/sarcopenia should be implemented as early as possible in patients' pathways, these syndromes being reversible at early stages but not at late stages.
A multidisciplinary assessment at diagnosis and therapeutic approach combining nutritional support and and adapted physical activity (APA) in addition to anticancer treatments should be systematically implemented in patients with advanced GI cancers.
This type of intervention complies with the standards recommended by the National Cancer Institute (INCa) to promote the practice of physical activity during and after treatment in oncology.
All patients will receive usual care including:
Nutritional support will consist of:
Physical activity support will consist of physical condition assessed by International Physical Activity Questionnaire (IPAQ), performance status (ECOG PS), resting heart rate and blood pressure, 6-minute walking test (speed, fatigue), handgrip test, chair stand fitness test, get-up and go test, balance in single-leg and bipodal stance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with advanced gastrointestinal (GI) cancers | Other | All patients will receive usual care including:
Nutritional support will consist of:
Physical activity support will consist of:
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|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multidisciplinary assessment and intervention | Other | early multidisciplinary assessment and intervention in addition to usual patient care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Program faisability | Program feasibility will be satisfactory if ≥ 80% of patients with advanced GI cancers included in the program complete the baseline, W4 and W8 assessments | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dimensions of EORTC QLQ-C30 | EORTC QLQ-C30 completion | 12 months |
| Fatigue measured by Visual Analogue Scale (VAS) | Visual Analogue Scale (VAS) completion, a score form 0 to 10 will be given |
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Inclusion Criteria:
Exclusion Criteria:
Note: participation to another concomitant clinical trial is allowed, but the patient must inform the Investigator and get an authorization from the Sponsor.
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| Name | Affiliation | Role |
|---|---|---|
| Véronique GILLON | Institut Curie | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Curie | Paris | 75005 | France |
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| 12 months |
| Pain measured by VAS and analgesics consumption | VAS completion and analgesics consumption report, a score form 0 to 10 will be given and report of analgesics consumption will be given by name and dose | 12 months |
| Nutritional status/inflammation measure | weight in kilograms, body mass index will be reported in BMI in kg/m^2, food intakes | 12 months |
| Physical condition assessed | International Physical Activity Questionnaire (IPAQ), | 12 months |
| Geriatric assessment if age ≥ 70 | G8 score from 0 to 17 | 12 months |
| Chemotherapy tolerance assessed | toxicities (using Common Terminology Criteria for Adverse Events [CTCAE v5.0]) | 12 months |
| Progression Free Survival and Overall Survival | Progression Free Survival and Overall Survival | 12 months |
| Patient's satisfaction measured by VAS | VAS completion with a score from 0 to 10 | 12 months |
| ID | Term |
|---|---|
| D018278 | Carcinoma, Neuroendocrine |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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