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ALDH Enzyme in CRF With Advanced GI Cancer

NCT05030363 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2022-01-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ALDH enzyme supplementation

ALDH enzyme (PICOZYMEQ™)

Sponsors & Collaborators

  • Korea University Anam Hospital

    lead OTHER

Principal Investigators

  • Soohyeon Lee, MD, PhD · Korea University Anam Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05030363 on ClinicalTrials.gov