The Efficacy of Aldehyde Dehydrogenase (ALDH) Enzyme in Chemotherapy-Related Fatigue with Advanced Gastrointestinal Cancer Patients: A Single-Center Study
- Conditions
- Neoplasms
- Registration Number
- KCT0006800
- Lead Sponsor
- Korea University Anam Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 82
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.
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of FACIT-F score
- Secondary Outcome Measures
Name Time Method Change of FACIT-F score ;Change of ESAS;Change of ESAS