Clinical trial · Interventional
ALDH Enzyme in CRF With Advanced GI Cancer
The Efficacy and Safety of Alcoholic Dehydrogenase (ALDH) Enzyme Supplement in Chemotherapy-Related Fatigue With Advanced Gastrointestinal Cancer Patients: A 2-Period, Crossover, Single-Center Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aldehyde Dehydrogenase | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALDH enzyme supplementation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Upfront ALDH enzyme supplement
- description
- 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).
- interventionNames
- Drug: ALDH enzyme supplementation
- type
- OTHER
- label
- Delayed ALDH enzyme supplement
- description
- 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).
- interventionNames
- Drug: ALDH enzyme supplementation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
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