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Impact of Anamorelin with unresectable pancreatic, gastric and colorectal cancer patients for a quality of life, skeletal muscle index and malnutrition

ABSTRACT: Primary outcome(s): Difference in QOL between non-Anamorelin usage and Anamorelin usage patients in 24 weeks (assessed by EORTC QLQ-C30)

DISEASE(S): Pancreatic Cancer Gastric Cancer Colorectal Cancer

PROVIDER: 2661537 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Primary objectives: • To evaluate the efficacy and tolerability of magnesium gluconate 3 g bid. given orally to modulate magnesium wasting in patients with colorectal cancer treated with EGFR targeted antibody therapy.• To evaluate the efficacy and tolerability of magnesium gluconate 3 g six times per day compared to 3 g bid. given orally to modulate magnesium wasting in patients with colorectal cancer with grade 2 hypomagnesemia induced by EGFR targeted antibody therapy Primary endpoints: After informed consent has been given, subjects meeting the inclusion criteria will be randomised to two different therapeutic approaches: • Arm A: No intervention (part 1), until appearance hypomagnesemia grade 1, followed by magnesium gluconate 3 g bid. orally (part 2)• Arm B: Prophylactic treatment with magnesium gluconate 3 g bid orally (part 1) until appearance of hypomagnesemia grade 1, followed by magnesium gluconate 3 g 6X/day orally (part 2)The primary efficacy variables of the part 1 of the study will be:• The slope of the change in serum magnesium levels since baseline• The mean number of bowel movements per day.The secondary efficacy variables of this part of the study will be:• The mean number of missed doses• The mean grade of fatigue according to CTC version 3.0• The QoL score at two-weekly intervals recorded with the QLQ-C30 questionnaire from EORTC. • Patients will end part 1 of the study, as soon as the subjects have one serum magnesium level with grade 1 hypomagnesemia. They will then be entered in part 2. The primary efficacy variables of part 2 of the study will be:• The slope of the change in serum magnesium levels since appearance of grade 1 hypomagnesaemia• The mean number of bowel movements per day.The secondary efficacy variables of this part of the study will be:• The mean number of missed doses • The mean grade of fatigue according to CTC version 3.0• The QOL score at two-weekly intervals recorded with the QLQ-C30 questionnaire from EORTC. •

Dataset Information

Impact of Anamorelin with unresectable pancreatic, gastric and colorectal cancer patients for a quality of life, skeletal muscle index and malnutrition

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