This is a monocentric, comparative, open-label, randomized parallel group study enrolling elderly subjects hospitalized in Strasbourg Europe Cancerology Institute (ICANS), starting chemotherapy or targeted therapy for the treatment of digestive cancer.
At the ICANS an EPODIG-G program, consisting in a coordination of supportive care that are existing in the Institute, is proposed to elderly patients with digestive cancer. The purpose of this study is to evaluate the impact of this early multidisciplinary geriatric program (EPODIG-G), when it is initiated before therapeutic treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
144
EPODIG-G program includes: a nutritional evaluation (laboratory tests: albumin, pre-albumin, C reactive protein and vitamin D dosage, nutritional status, Handgrip test, Simple Evaluation of Food Intake (SEFI), spontaneous food intake evaluation) ; a medication reconciliation ; physical therapy (Six Minute Walk Test)
Institut de cancérologie Strasbourg Europe
Strasbourg, France
RECRUITINGImpact of EPODIG-G program on treatment.
Number of patients who benefit from all programmed treatment cycles at 24 weeks
Time frame: 24 weeks after treatment initiation
Dose-intensity evaluation. Cumulative doses and theoretical doses of chemotherapy or targeted therapy.
Time frame: 24 weeks after treatment initiation
Number of adverse events and serious adverse events according to CTCAE v5.0.
Time frame: throughout treatment, at 8, 16 and 24 weeks after treatment initiation
Progression free survival
Time frame: 3 years after last inclusion
Overall survival
Time frame: 3 years after last inclusion
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