drugset / Trial / NCT05030363

ALDH Enzyme in CRF With Advanced GI Cancer

NCT05030363 ↗

Unknown 82 enrolled Korea University Anam Hospital
RandomizedCrossoverOpen-labelSupportive care

Summary

Aldehyde dehydrogenase (ALDH) enzyme supplementation plays an essential role in the elimination of toxic metabolites and reduction of reactive oxygen species bioactivation, which can protect and relieve chemotherapy-related fatigue (CRF) in cancer patients. The aim of this study is to evaluate the efficacy and safety of ALDH enzyme in CRF with advanced gastrointestinal cancer patients. The primary endpoint is the change of FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) score on day 15 compared to baseline after chemotherapy. The secondary endpoint including change of FACIT-F on day 29 compared to day 15, change of ESAS (Edmonton Symptom Assessment System) on day 15 compared to baseline, safety and toxicities, and exploratory biomarkers.

Timeline

Start
2021-10-25
Primary completion
2022-08-31
Completion
2022-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject ALDH enzyme Unknown — —