Institut Curie
Paris, 75005, France
NCT Number: NCT04478175
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Paris, 75005, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
early multidisciplinary assessment and intervention in addition to usual patient care
Time frame: 12 months
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
EORTC QLQ-C30 completion
Time frame: 12 months
Visual Analogue Scale (VAS) completion, a score form 0 to 10 will be given
Time frame: 12 months
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
weight in kilograms, body mass index will be reported in BMI in kg/m^2, food intakes
Time frame: 12 months
International Physical Activity Questionnaire (IPAQ),
Time frame: 12 months
G8 score from 0 to 17
Time frame: 12 months
toxicities (using Common Terminology Criteria for Adverse Events [CTCAE v5.0])
Time frame: 12 months
Progression Free Survival and Overall Survival
Time frame: 12 months
VAS completion with a score from 0 to 10
Institut Curie
Other
Prospective Evaluation of a Program for Early Identification of Needs and Multidisciplinary Intervention in Supportive Care in Digestive Oncology - DISSPO Parcours Dig' Study
Acronym: DParcoursDig
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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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