ALDH Enzyme in CRF With Advanced GI Cancer

Fatigue Clinical Trial

— ALDHCRF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05030363
• Other study ID #: PicoEnTech001
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2021
• Source: Korea University Anam Hospital
• Contact: Soohyeon Lee, M.D., Ph.D.
• Phone: 82-2-920-5690
• Email: soohyeon_lee[@]korea.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Chemotherapy-related fatigue (CRF) occurs universally in cancer patients which can be a debilitating symptom that affects patients' quality of life. The impact of CRF has been associated with mood disorder, sleep disturbance, cognitive dysfunction, inflammation mediated putative biological disturbances, and functional morbidities. Although the etiology is heterogeneous and complex, one of the proposed mechanisms is that chemotherapy induced multiple oxidative degradation of the lipid membrane which generates reactive oxygen species (ROS) and tissue damage. These conditions result in inflammation-induced reduction in central dopaminergic neurotransmission, nutritional deficiency (especially in vitamins and minerals), and immunodeficiency, which clinically manifest as CRF. To date, various agents including psychostimulants (methylphenidate, donepezil, and modafinil), dexamethasone, and Korean red ginseng (KRG) were used in the management of CRF. However, the prevalence of CRF is still high primarily due to lack of proven effective therapies. ALDH enzyme supplementation plays an essential role in the eliminates 4-hydoxynonenal, malondialdehyde from lipid peroxidation and reduce ROS bioactivation, which can protect and relieve CRF in cancer patients. Based on these rational backgrounds, the aim or this study is to evaluate the efficacy and safety of ALDH enzyme in CRF with advanced gastrointestinal cancer patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: December 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatigue
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Drug:
• ALDH enzyme supplementation
ALDH enzyme (PICOZYMEQ™)

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of FACIT-F score	Change of FACIT-F score on day 15 compared to baseline after chemotherapy	Day 15 compared to baseline
Secondary	Change of FACIT-F score	Change of FACIT-F score on day 29 compared to day 15 after chemotherapy	Day 29 compared to day 15
Secondary	Change of ESAS	Change of ESAS on day 15 compared to baseline after chemotherapy	Day 15 compared to baseline
Secondary	Change of ESAS	Change of ESAS on day 29 compared to day 15 after chemotherapy	Day 29 compared to day 15
Secondary	Incidence of treatment-related adverse events	Safety and tolerability assessments	Day 15 and 29
Secondary	Exploratory biomarker studies - Urine malondialdehyde - ALDH2 polymorphism (ALDH2 *1/*2, rs671 A/G) - Change of inflammatory cytokines	Analysis Inflammatory cytokine and metabolites during ALDH enzyme supplement and explore predictive biomarker using urine malondialdehyde	Day 1, 15 and 29