ALDH Enzyme in CRF With Advanced GI Cancer (ALDHCRF)
Fatigue, Gastrointestinal Cancer, Aldehyde Dehydrogenase
About this trial
This is an interventional supportive care trial for Fatigue focused on measuring Chemotherapy-Related Fatigue, Gastrointestinal Cancer, Aldehyde Dehydrogenase
Eligibility Criteria
Inclusion Criteria:
To be included in the trial, subjects must meet all of the following criteria:
- Fatigue score ≥ 4 on analog scale of 0 to 10 (0; not at all, 10; worst possible fatigue) for more than 1 week.
- Subject has willing and able to written informed consent form (ICF) prior to any screening procedures.
- Age ≥ 19 years old of male and female.
- Life expectancy more than 3 months.
Exclusion Criteria:
- Hb < 8g/dL
- Uncontrolled hyper- or hypothyroidism despite of appropriate treatment
- Evidence of central nervous system (CNS) tumor metastasis; permitted if asymptomatic or neurologically stable.
- Sign of active and uncontrolled bacterial or viral infection requiring systemic therapy
- Abnormal cognition status or psychiatric disease.
- Anamnesis of hypersensitivity reaction to the ALDH enzyme.
- 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.
- Medical conditions that could affect trial outcomes or subjects who were considered unsuitable for trial enrollment by the investigator.
Sites / Locations
- Korea University Anam HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Upfront ALDH enzyme supplement
Delayed ALDH enzyme supplement
Upfront ALDH enzyme supplement; After randomization, patients will receive ALDH enzyme supplement twice a day for consecutive 14 days during chemotherapy (period 1; day 1 to day 14) until unacceptable toxicity, or consent withdrawal. Patients will visit clinic on day 15, then will be followed on day 29 without ALDH enzyme administration during subsequent chemotherapy (period 2).
Delayed ALDH enzyme supplement; patients will not take ALDH enzyme supplement during chemotherapy after randomization on day 1 to day 14 (period 1). On day 15, Patients will visit for subsequent chemotherapy and start ALDH enzyme supplement twice a day for 14 consecutive days during chemotherapy (period 2; day 15 to day 29).