ALDHCRF: ALDH Enzyme in CRF With Advanced GI Cancer

Sponsor
Korea University Anam Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05030363
Collaborator
(none)
82
1
2
14.2
5.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: ALDH enzyme supplementation
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
A 2-Period, Crossover, Single-Center StudyA 2-Period, Crossover, Single-Center Study
Masking:
None (Open Label)
Masking Description:
Open label
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Oct 25, 2021
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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).

Drug: ALDH enzyme supplementation
ALDH enzyme (PICOZYMEQ™)

Other: 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).

Drug: ALDH enzyme supplementation
ALDH enzyme (PICOZYMEQ™)

Outcome Measures

Primary Outcome Measures

  1. Change of FACIT-F score [Day 15 compared to baseline]

    Change of FACIT-F score on day 15 compared to baseline after chemotherapy

Secondary Outcome Measures

  1. Change of FACIT-F score [Day 29 compared to day 15]

    Change of FACIT-F score on day 29 compared to day 15 after chemotherapy

  2. Change of ESAS [Day 15 compared to baseline]

    Change of ESAS on day 15 compared to baseline after chemotherapy

  3. Change of ESAS [Day 29 compared to day 15]

    Change of ESAS on day 29 compared to day 15 after chemotherapy

  4. Incidence of treatment-related adverse events [Day 15 and 29]

    Safety and tolerability assessments

  5. Exploratory biomarker studies - Urine malondialdehyde - ALDH2 polymorphism (ALDH2 *1/*2, rs671 A/G) - Change of inflammatory cytokines [Day 1, 15 and 29]

    Analysis Inflammatory cytokine and metabolites during ALDH enzyme supplement and explore predictive biomarker using urine malondialdehyde

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Korea University Anam Hospital Seoul Korea, Republic of 02841

Sponsors and Collaborators

  • Korea University Anam Hospital

Investigators

  • Principal Investigator: Soohyeon Lee, MD, PhD, Korea University Anam Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Korea University Anam Hospital
ClinicalTrials.gov Identifier:
NCT05030363
Other Study ID Numbers:
  • PicoEnTech001
First Posted:
Sep 1, 2021
Last Update Posted:
Jan 11, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Korea University Anam Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2022