ALDH Enzyme in CRF With Advanced GI Cancer

• Status: Not yet recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea University Anam Hospital

Criteria

Inclusion Criteria:

To be included in the trial, subjects must meet all of the following criteria:

1. Fatigue score ≥ 4 on analog scale of 0 to 10 (0; not at all, 10; worst possible fatigue) for more than 1 week.

2. Subject has willing and able to written informed consent form (ICF) prior to any screening procedures.

3. Age ≥ 19 years old of male and female.

4. Life expectancy more than 3 months.

Exclusion Criteria:

1. Hb < 8g/dL

2. Uncontrolled hyper- or hypothyroidism despite of appropriate treatment

3. Evidence of central nervous system (CNS) tumor metastasis; permitted if asymptomatic or neurologically stable.

4. Sign of active and uncontrolled bacterial or viral infection requiring systemic therapy

5. Abnormal cognition status or psychiatric disease.

6. Anamnesis of hypersensitivity reaction to the ALDH enzyme.

7. Current use or previous use within 14 days of the following medications:

Korean-Chinese medications, methylphenidate, modafinil, phenobarbital, diphenylhydantoin, primidone, phenylbutazone, monoamine oxidase inhibitors, clonidine, and tricyclic antidepressants.

8. Medical conditions that could affect trial outcomes or subjects who were considered unsuitable for trial enrollment by the investigator.