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ALDH Enzyme in CRF With Advanced GI Cancer (ALDHCRF)

Primary Purpose

Fatigue, Gastrointestinal Cancer, Aldehyde Dehydrogenase

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ALDH enzyme supplementation
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fatigue focused on measuring Chemotherapy-Related Fatigue, Gastrointestinal Cancer, Aldehyde Dehydrogenase

Eligibility Criteria

19 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Korea University Anam HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Upfront ALDH enzyme supplement

Delayed ALDH enzyme supplement

Arm 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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change of FACIT-F score
Change of FACIT-F score on day 29 compared to day 15 after chemotherapy
Change of ESAS
Change of ESAS on day 15 compared to baseline after chemotherapy
Change of ESAS
Change of ESAS on day 29 compared to day 15 after chemotherapy
Incidence of treatment-related adverse events
Safety and tolerability assessments
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

Full Information

First Posted
August 9, 2021
Last Updated
December 24, 2021
Sponsor
Korea University Anam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05030363
Brief Title
ALDH Enzyme in CRF With Advanced GI Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Korea University Anam Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Gastrointestinal Cancer, Aldehyde Dehydrogenase
Keywords
Chemotherapy-Related Fatigue, Gastrointestinal Cancer, Aldehyde Dehydrogenase

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
A 2-Period, Crossover, Single-Center Study
Masking
None (Open Label)
Masking Description
Open label
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Upfront ALDH enzyme supplement
Arm Type
Experimental
Arm 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).
Arm Title
Delayed ALDH enzyme supplement
Arm Type
Other
Arm 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).
Intervention Type
Drug
Intervention Name(s)
ALDH enzyme supplementation
Intervention Description
ALDH enzyme (PICOZYMEQ™)
Primary Outcome Measure Information:
Title
Change of FACIT-F score
Description
Change of FACIT-F score on day 15 compared to baseline after chemotherapy
Time Frame
Day 15 compared to baseline
Secondary Outcome Measure Information:
Title
Change of FACIT-F score
Description
Change of FACIT-F score on day 29 compared to day 15 after chemotherapy
Time Frame
Day 29 compared to day 15
Title
Change of ESAS
Description
Change of ESAS on day 15 compared to baseline after chemotherapy
Time Frame
Day 15 compared to baseline
Title
Change of ESAS
Description
Change of ESAS on day 29 compared to day 15 after chemotherapy
Time Frame
Day 29 compared to day 15
Title
Incidence of treatment-related adverse events
Description
Safety and tolerability assessments
Time Frame
Day 15 and 29
Title
Exploratory biomarker studies - Urine malondialdehyde - ALDH2 polymorphism (ALDH2 *1/*2, rs671 A/G) - Change of inflammatory cytokines
Description
Analysis Inflammatory cytokine and metabolites during ALDH enzyme supplement and explore predictive biomarker using urine malondialdehyde
Time Frame
Day 1, 15 and 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soohyeon Lee, M.D., Ph.D.
Phone
82-2-920-5690
Email
soohyeon_lee@korea.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soohyeon Lee, MD, PhD
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soohyeon Lee, M.D., Ph.D.
Email
soohyeon_lee@korea.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
No

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ALDH Enzyme in CRF With Advanced GI Cancer

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