An interventional study of multidisciplinary assessment and intervention in Non-colorectal Cancer (Esophagus, Stomach, Liver/Bile Ducts, Pancreas, Neuroendocrine Carcinoma) and Colorectal With Associated Risk Factors, sponsored by Institut Curie. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-17.
Sponsored by Institut Curie · Not applicable, Interventional, and Supportive care
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.
236 studies on the registry are indexed under Carcinoma, Neuroendocrine; 66 are open to participants now.
This study's enrollment of 30 is below the median of 52 across 184 interventional studies indexed under Carcinoma, Neuroendocrine.
Browse Carcinoma, Neuroendocrine studies →Institut Curie is the lead sponsor of 134 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
All patients will receive usual care including: * Chemotherapy at the investigator's choice, * Outpatient clinical visits according to the regular schedule, * Tumor evaluation based on tumor marker serum levels, as appropriate, and TAP-CT with intravenous contrast injection every 8 weeks. Nutritional support will consist of: * A nutrition assessment by a dieticianat W4 and W8 (plus additional visits if required), * Nutritional intervention ± oral supplementation, enteral tube feeding, and/or parenteral nutrition). Physical activity support will consist of: * A physical condition assessment by a APA profesional including physical tests (6-minute walking test, handgrip test, chair stand fitness test, get-up and go test, balance in single-leg and bipodal stance) at baseline, W4 and W8, * Personalized counselling for unsupervised home-based exercises
Other: multidisciplinary assessment and intervention
early multidisciplinary assessment and intervention in addition to usual patient care
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
Time frame: 12 months
Dimensions of EORTC QLQ-C30
EORTC QLQ-C30 completion
Time frame: 12 months
Fatigue measured by Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) completion, a score form 0 to 10 will be given
Time frame: 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
Time frame: 12 months
Nutritional status/inflammation measure
weight in kilograms, body mass index will be reported in BMI in kg/m\^2, food intakes
Time frame: 12 months
Physical condition assessed
International Physical Activity Questionnaire (IPAQ),
Time frame: 12 months
Geriatric assessment if age ≥ 70
G8 score from 0 to 17
Time frame: 12 months
Chemotherapy tolerance assessed
toxicities (using Common Terminology Criteria for Adverse Events \[CTCAE v5.0\])
Time frame: 12 months
Progression Free Survival and Overall Survival
Progression Free Survival and Overall Survival
Time frame: 12 months
Patient's satisfaction measured by VAS
VAS completion with a score from 0 to 10
Time frame: 12 months
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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