None listed
Conditions
Interventions
Drug : This trial is a randomized, open-label, cross-over study to evaluate the efficacy and safety of ALDH enzyme in chemotherapy-related fatigue with advanced gastrointestinal cancer patients. Patie
Sponsors
Korea University Anam Hospital
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of FACIT-F score | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of FACIT-F score ;Change of ESAS;Change of ESAS | — |
Countries
Korea, Republic of
Contacts
Public ContactSoohyeon Lee
Korea University Anam Hospital
Outcome results
None listed