Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)

PHASE3RecruitingINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

April 8, 2025

Primary Completion Date

December 30, 2026

Study Completion Date

December 30, 2026

Conditions
Gynecologic CancerAnemiaIron-deficiency
Interventions
DRUG

Ferric derisomaltose

Ferric Derisomaltose is a solution based iron supplement provided in 100 mg elemental iron/mL. Patients randomized to Iron Therapy Arm will with a bodyweight \<50kg will receive 500mg of Ferric Derisomaltose, and patients with a bodyweight \>50kg will receive 1000mg of Ferric Derisomaltose, to ensure no patient exceeds the manufacturer's recommended dose of 20mg/kg. Patients will receive a single infusion between 21 and 90 days preceding surgical intervention.

DRUG

Placebo

Patients randomized to the Placebo arm will receive 100mg of normal saline over 1 hour.

Trial Locations (1)

T2N 5G2

RECRUITING

Arthur J.E. Child Comprehensive Cancer Centre, Calgary

All Listed Sponsors
lead

AHS Cancer Control Alberta

OTHER