<HashMap><database>ecrin-mdr-crc</database><scores/><additional><omics_type>Clinical</omics_type><study_start_year>2020</study_start_year><condition>Unresectable, advanced or recurrent colorectal cancer</condition><disease>Unresectable, Advanced Or Recurrent Colorectal Cancer</disease><study_type>Interventional</study_type><full_dataset_link>https://newmdr.ecrin.org/Study/2614948</full_dataset_link><study_start_month>3</study_start_month><repository>ECRIN MDR</repository><study_status>Active, not recruiting</study_status></additional><is_claimable>false</is_claimable><name>NYX study</name><description>Interventions: arm A: Oral administration of TSUMURA Ninjin’yoeito 9.0 g/day in 2 or 3 divided doses before or between meals, from the day 1 of the first cycle to the last day of the 8th cycle in CapeOX + Bmab therapy.
arm B: Non-treatment of TSUMURA Ninjin’yoeito.
Primary outcome(s): 1. Maintenance of nutritional status (CONUT)
2. Incidence of non-hematological adverse events >= grade 3 of CapeOX +Bmab therapy
Study Design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose</description><dates><creation>2020-03-15</creation></dates><accession>2614948</accession><cross_references><Japan Primary Registries Network>JPRN-jRCTs041190071</Japan Primary Registries Network></cross_references></HashMap>