ALDH Enzyme in CRF With Advanced GI Cancer

NCT ID: NCT05030363

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-25
• Study Completion Date: 2022-12-31

Brief 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.

Detailed 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.

Conditions

Fatigue; Gastrointestinal Cancer; Aldehyde Dehydrogenase

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Upfront 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).

Group Type: EXPERIMENTAL

ALDH enzyme supplementation

Intervention Type: DRUG

ALDH enzyme (PICOZYMEQ™)

Delayed ALDH enzyme supplement

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).

Group Type: OTHER

ALDH enzyme supplementation

Intervention Type: DRUG

ALDH enzyme (PICOZYMEQ™)

Interventions

ALDH enzyme supplementation

ALDH enzyme (PICOZYMEQ™)

Intervention Type: DRUG

Eligibility 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

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea University Anam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Soohyeon Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Korea University Anam Hospital

Locations

Korea University Anam Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Soohyeon Lee, M.D., Ph.D.

Role: CONTACT

soohyeon_lee@korea.ac.kr

82-2-920-5690

Facility Contacts

Soohyeon Lee, M.D., Ph.D.

Role: primary

soohyeon_lee@korea.ac.kr

Other Identifiers

PicoEnTech001

Identifier Type: -

Identifier Source: org_study_id