search
Back to results

The Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults Who Have Received Cancer Treatment

Primary Purpose

Fatigue, Cancer, Treatment-Related

Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Redsenol-1 Plus
Placebo
Sponsored by
Canada Royal Enoch Phytomedicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue focused on measuring Safety and efficacy, Cancer-related fatigue, Ginseng

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Males and females between 18 and 65 years of age Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or, Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include: Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System) Double-barrier method Intrauterine devices Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) Vasectomy of partner at least 6 months prior to screening Individuals who have completed cancer treatment (radiation, chemotherapy, immunotherapy, target therapy, surgery) but not within two months prior to baseline and not scheduled for further treatment during the study period. Select patient populations on stable baseline therapy may be included at the discretion of the QI. Individuals with CRF defined as a score of ≥4 on the CRF Single-Item Scale (an 11-point scale where 0 is "no fatigue" and 10 is "as bad as it can be") CRF present for at least one month prior to screening Eastern Cooperative Oncology Group (ECOG) Performance Status Scale score ≤2 Hemoglobin level of ≥110 g/L for females and ≥129 g/L for males at screening Agrees to maintain current lifestyle habits as much as possible throughout the study depending on ability to maintain the following: diet, medications, supplements, exercise, and sleep and avoid taking new supplements during the study period Provided voluntary, written, informed consent to participate in the study Otherwise healthy as determined by medical history and laboratory results as assessed by Qualified Investigator (QI) while taking into consideration the participant's cancer history Exclusion Criteria: Individuals who are pregnant, breast feeding, or planning to become pregnant during the study Allergy, sensitivity, or intolerance to the investigational product's or placebo's active or inactive ingredients Individuals with any CNS malignancies (e.g., brain or spine) and/or estrogen-receptor positive breast cancer Individuals with other primary causes of fatigue, as assessed by the QI (e.g., diagnosed non-cancer related chronic pain, insomnia/sleep disorders, depression/psychiatric disorders, unstable hypothyroidism, diabetes) Individuals with unstable medical conditions as assessed by the QI Individuals with current untreated/uncontrolled high blood pressure or tachycardia/heart rhythm disorders Individuals with >7.5% HbA1c with treatment for high blood sugar/diabetes or individuals with ≥6.5% HbA1c without treatment Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months Major non-cancer surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI Current use of prescription/OTC medications and/or supplements and food/drinks which may affect the efficacy and/ or safety of the IP (see Sections 7.3.1 and 7.3.2) Alcohol or drug abuse within the last 12 months Frequent (daily) and chronic cannabis users. Occasional (e.g., once per month) cannabis users may be included at the discretion of the QI and if eligible, asked to stop cannabis use for study period Clinically significant abnormal laboratory results at screening as assessed by the QI Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI Individuals who are unable to give informed consent Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Sites / Locations

  • KGK Science Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Redsenol-1 Plus

Placebo

Arm Description

Participants will be instructed to take two (2) capsules, three (3) times a day in the morning, at noon and in the evening (before going to bed), for a total of 6 capsules a day, with food for 12 weeks. If a dose is missed participants are instructed to take the missed dose as soon as possible.

Participants will be instructed to take two (2) capsules, three (3) times a day in the morning, at noon and in the evening (before going to bed), for a total of 6 capsules a day, with food for 12 weeks. If a dose is missed participants are instructed to take the missed dose as soon as possible.

Outcomes

Primary Outcome Measures

The change in the severity of cancer-related fatigue from baseline to week 12.
The change in the severity of cancer-related fatigue from baseline to week 12 as assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue subscale will be compared between Redsenol-1 Plus and placebo.

Secondary Outcome Measures

The difference in change of severity of cancer-related fatigue from baseline to weeks 4 and 8.
The difference in change of severity of cancer-related fatigue from baseline to weeks 4 and 8 as assessed by the FACIT-F fatigue subscale will be compared between Redsenol-1 Plus and placebo.
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12 between Redsenol-1 Plus compared to placebo as assessed by the FACIT-F total score.
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12 between Redsenol-1 Plus compared to placebo as assessed by the FACIT-F physical well-being (PWB) sub-scale.
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12 between Redsenol-1 Plus compared to placebo as assessed by the social well-being (SWB) sub-scale.
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12 between Redsenol-1 Plus compared to placebo as assessed by the emotional well-being (EWB) sub-scale.
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12 between Redsenol-1 Plus compared to placebo as assessed by the functional well-being (FWB) sub-scale.
The difference in the proportion of participants who have a clinically important change in severity of cancer-related fatigue from baseline to 4 weeks, 8 weeks, and 12 weeks.
The difference in the proportion of participants who have a clinically important change in severity of cancer-related fatigue as assessed by the FACIT-F fatigue subscales from baseline to 4 weeks, 8 weeks, and 12 weeks between Redsenol-1 Plus compared to placebo.
The difference in performance status from baseline to weeks 4, 8, and 12.
The difference in performance status as assessed by the Eastern Cooperative Oncology Group (ECOG) tool from baseline to weeks 4, 8, and 12 between Redsenol-1 Plus compared to placebo.
The difference in mood from baseline to weeks 4, 8, and 12.
The difference in mood as assessed by the Profile of Mood States (POMS) questionnaire from baseline to weeks 4, 8, and 12 between Redsenol-1 Plus compared to placebo.
Incidence of pre-emergent and post-emergent adverse events following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Blood pressure at baseline and following supplementation with Redsenol-1 Plus or placebo for 4 weeks, 8 weeks, and 12 weeks.
Heart rate at baseline and following supplementation with Redsenol-1 Plus or placebo for 4 weeks, 8 weeks, and 12 weeks.
Aspartate aminotransferase (AST) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Aspartate aminotransferase (AST) will be measured in blood from study participants at 12 weeks.
Alanine aminotransferase (ALT) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Alanine aminotransferase (ALT) will be measured in blood from study participants at 12 weeks.
Alkaline phosphatase (ALP) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Alkaline phosphatase (ALP) will be measured in blood from study participants at 12 weeks.
Bilirubin measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Total bilirubin will be measured in blood from study participants at 12 weeks.
Creatinine measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Creatinine will be measured in blood from study participants at 12 weeks.
Measurement of electrolytes (Na, K ,Cl) following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Electrolytes will be measured in blood from study participants at 12 weeks.
Measurement of glucose following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Glucose will be measured in blood from study participants at 12 weeks.
Estimated glomerular filtration rate (eGFR) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Estimated glomerular filtration rate (eGFR) will be measured in blood from study participants at 12 weeks.
White blood cell count measurements following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
White blood cell count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils) will be measured in blood from study participants at 12 weeks.
Red blood cell count measurements following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Red blood cell count will be measured in blood from study participants at 12 weeks.
Hemoglobin measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Hemoglobin will be measured in blood from study participants at 12 weeks.
Hematocrit measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Hematocrit will be measured in blood from study participants at 12 weeks.
Platelet count measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Platelet count will be measured in blood from study participants at 12 weeks.
Mean corpuscular volume measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Mean corpuscular volume will be measured in blood from study participants at 12 weeks.
Mean corpuscular hemoglobin measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Mean corpuscular hemoglobin will be measured in blood from study participants at 12 weeks.
Mean corpuscular hemoglobin concentration measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Mean corpuscular hemoglobin concentration will be measured in blood from study participants at 12 weeks.
Red blood cell distribution width measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Red blood cell distribution will be measured in blood from study participants at 12 weeks.
Immature granulocyte measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Immature granulocytes will be measured in blood from study participants at 12 weeks.
Nucleated red blood cell measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Nucleated red blood cells will be measured in blood from study participants at 12 weeks.
Incidence of adverse events during the follow-up period (weeks 12-16).

Full Information

First Posted
December 8, 2022
Last Updated
September 5, 2023
Sponsor
Canada Royal Enoch Phytomedicine Co., Ltd.
Collaborators
KGK Science Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05664009
Brief Title
The Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults Who Have Received Cancer Treatment
Official Title
A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults Who Have Received Cancer Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canada Royal Enoch Phytomedicine Co., Ltd.
Collaborators
KGK Science Inc.

4. Oversight

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

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the safety and efficacy of Redsenol-1 Plus on cancer-related fatigue (CRF) in adults who have received cancer treatment. The change in the severity of CRF from baseline at week 12 will be assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue subscale, and compared between Redsenol-1 Plus and placebo groups. Additionally, the safety and tolerability of Redsenol-1 Plus, as compared to placebo, will be measured by the occurrence of and/or changes in treatment-emergent adverse events (AEs).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Cancer, Treatment-Related
Keywords
Safety and efficacy, Cancer-related fatigue, Ginseng

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Redsenol-1 Plus
Arm Type
Experimental
Arm Description
Participants will be instructed to take two (2) capsules, three (3) times a day in the morning, at noon and in the evening (before going to bed), for a total of 6 capsules a day, with food for 12 weeks. If a dose is missed participants are instructed to take the missed dose as soon as possible.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be instructed to take two (2) capsules, three (3) times a day in the morning, at noon and in the evening (before going to bed), for a total of 6 capsules a day, with food for 12 weeks. If a dose is missed participants are instructed to take the missed dose as soon as possible.
Intervention Type
Dietary Supplement
Intervention Name(s)
Redsenol-1 Plus
Intervention Description
Two capsules of Redsenol-1 Plus will be taken three times per day for 12 weeks (84 days).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Two capsules of Placebo will be taken three times per day for 12 weeks (84 days).
Primary Outcome Measure Information:
Title
The change in the severity of cancer-related fatigue from baseline to week 12.
Description
The change in the severity of cancer-related fatigue from baseline to week 12 as assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue subscale will be compared between Redsenol-1 Plus and placebo.
Time Frame
baseline and 84 days
Secondary Outcome Measure Information:
Title
The difference in change of severity of cancer-related fatigue from baseline to weeks 4 and 8.
Description
The difference in change of severity of cancer-related fatigue from baseline to weeks 4 and 8 as assessed by the FACIT-F fatigue subscale will be compared between Redsenol-1 Plus and placebo.
Time Frame
baseline, 28 days, 56 days
Title
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
Description
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12 between Redsenol-1 Plus compared to placebo as assessed by the FACIT-F total score.
Time Frame
baseline, 28 days, 56 days, 84 days
Title
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
Description
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12 between Redsenol-1 Plus compared to placebo as assessed by the FACIT-F physical well-being (PWB) sub-scale.
Time Frame
baseline, 28 days, 56 days, 84 days
Title
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
Description
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12 between Redsenol-1 Plus compared to placebo as assessed by the social well-being (SWB) sub-scale.
Time Frame
baseline, 28 days, 56 days, 84 days
Title
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
Description
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12 between Redsenol-1 Plus compared to placebo as assessed by the emotional well-being (EWB) sub-scale.
Time Frame
baseline, 28 days, 56 days, 84 days
Title
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12.
Description
The difference in change of cancer-related quality of life (QoL) from baseline at weeks 4, 8 and 12 between Redsenol-1 Plus compared to placebo as assessed by the functional well-being (FWB) sub-scale.
Time Frame
baseline, 28 days, 56 days, 84 days
Title
The difference in the proportion of participants who have a clinically important change in severity of cancer-related fatigue from baseline to 4 weeks, 8 weeks, and 12 weeks.
Description
The difference in the proportion of participants who have a clinically important change in severity of cancer-related fatigue as assessed by the FACIT-F fatigue subscales from baseline to 4 weeks, 8 weeks, and 12 weeks between Redsenol-1 Plus compared to placebo.
Time Frame
baseline, 28 days, 56 days, 84 days
Title
The difference in performance status from baseline to weeks 4, 8, and 12.
Description
The difference in performance status as assessed by the Eastern Cooperative Oncology Group (ECOG) tool from baseline to weeks 4, 8, and 12 between Redsenol-1 Plus compared to placebo.
Time Frame
baseline, 28 days, 56 days, 84 days
Title
The difference in mood from baseline to weeks 4, 8, and 12.
Description
The difference in mood as assessed by the Profile of Mood States (POMS) questionnaire from baseline to weeks 4, 8, and 12 between Redsenol-1 Plus compared to placebo.
Time Frame
baseline, 28 days, 56 days, 84 days
Title
Incidence of pre-emergent and post-emergent adverse events following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Time Frame
84 days
Title
Blood pressure at baseline and following supplementation with Redsenol-1 Plus or placebo for 4 weeks, 8 weeks, and 12 weeks.
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks
Title
Heart rate at baseline and following supplementation with Redsenol-1 Plus or placebo for 4 weeks, 8 weeks, and 12 weeks.
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks
Title
Aspartate aminotransferase (AST) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Description
Aspartate aminotransferase (AST) will be measured in blood from study participants at 12 weeks.
Time Frame
84 days
Title
Alanine aminotransferase (ALT) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Description
Alanine aminotransferase (ALT) will be measured in blood from study participants at 12 weeks.
Time Frame
84 days
Title
Alkaline phosphatase (ALP) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Description
Alkaline phosphatase (ALP) will be measured in blood from study participants at 12 weeks.
Time Frame
84 days
Title
Bilirubin measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Description
Total bilirubin will be measured in blood from study participants at 12 weeks.
Time Frame
84 days
Title
Creatinine measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Description
Creatinine will be measured in blood from study participants at 12 weeks.
Time Frame
84 days
Title
Measurement of electrolytes (Na, K ,Cl) following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Description
Electrolytes will be measured in blood from study participants at 12 weeks.
Time Frame
84 days
Title
Measurement of glucose following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Description
Glucose will be measured in blood from study participants at 12 weeks.
Time Frame
84 days
Title
Estimated glomerular filtration rate (eGFR) measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Description
Estimated glomerular filtration rate (eGFR) will be measured in blood from study participants at 12 weeks.
Time Frame
84 days
Title
White blood cell count measurements following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Description
White blood cell count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils) will be measured in blood from study participants at 12 weeks.
Time Frame
84 days
Title
Red blood cell count measurements following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Description
Red blood cell count will be measured in blood from study participants at 12 weeks.
Time Frame
84 days
Title
Hemoglobin measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Description
Hemoglobin will be measured in blood from study participants at 12 weeks.
Time Frame
84 days
Title
Hematocrit measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Description
Hematocrit will be measured in blood from study participants at 12 weeks.
Time Frame
84 days
Title
Platelet count measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Description
Platelet count will be measured in blood from study participants at 12 weeks.
Time Frame
84 days
Title
Mean corpuscular volume measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Description
Mean corpuscular volume will be measured in blood from study participants at 12 weeks.
Time Frame
84 days
Title
Mean corpuscular hemoglobin measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Description
Mean corpuscular hemoglobin will be measured in blood from study participants at 12 weeks.
Time Frame
84 days
Title
Mean corpuscular hemoglobin concentration measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Description
Mean corpuscular hemoglobin concentration will be measured in blood from study participants at 12 weeks.
Time Frame
84 days
Title
Red blood cell distribution width measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Description
Red blood cell distribution will be measured in blood from study participants at 12 weeks.
Time Frame
84 days
Title
Immature granulocyte measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Description
Immature granulocytes will be measured in blood from study participants at 12 weeks.
Time Frame
84 days
Title
Nucleated red blood cell measurement following supplementation with Redsenol-1 Plus or placebo for 12 weeks.
Description
Nucleated red blood cells will be measured in blood from study participants at 12 weeks.
Time Frame
84 days
Title
Incidence of adverse events during the follow-up period (weeks 12-16).
Time Frame
112 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females between 18 and 65 years of age Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or, Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include: Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System) Double-barrier method Intrauterine devices Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) Vasectomy of partner at least 6 months prior to screening Individuals who have completed cancer treatment (radiation, chemotherapy, immunotherapy, target therapy, surgery) but not within two months prior to baseline and not scheduled for further treatment during the study period. Select patient populations on stable baseline therapy may be included at the discretion of the QI. Individuals with CRF defined as a score of ≥4 on the CRF Single-Item Scale (an 11-point scale where 0 is "no fatigue" and 10 is "as bad as it can be") CRF present for at least one month prior to screening Eastern Cooperative Oncology Group (ECOG) Performance Status Scale score ≤2 Hemoglobin level of ≥110 g/L for females and ≥129 g/L for males at screening Agrees to maintain current lifestyle habits as much as possible throughout the study depending on ability to maintain the following: diet, medications, supplements, exercise, and sleep and avoid taking new supplements during the study period Provided voluntary, written, informed consent to participate in the study Otherwise healthy as determined by medical history and laboratory results as assessed by Qualified Investigator (QI) while taking into consideration the participant's cancer history Exclusion Criteria: Individuals who are pregnant, breast feeding, or planning to become pregnant during the study Allergy, sensitivity, or intolerance to the investigational product's or placebo's active or inactive ingredients Individuals with any CNS malignancies (e.g., brain or spine) and/or estrogen-receptor positive breast cancer Individuals with other primary causes of fatigue, as assessed by the QI (e.g., diagnosed non-cancer related chronic pain, insomnia/sleep disorders, depression/psychiatric disorders, unstable hypothyroidism, diabetes) Individuals with unstable medical conditions as assessed by the QI Individuals with current untreated/uncontrolled high blood pressure or tachycardia/heart rhythm disorders Individuals with >7.5% HbA1c with treatment for high blood sugar/diabetes or individuals with ≥6.5% HbA1c without treatment Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months Major non-cancer surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI Current use of prescription/OTC medications and/or supplements and food/drinks which may affect the efficacy and/ or safety of the IP (see Sections 7.3.1 and 7.3.2) Alcohol or drug abuse within the last 12 months Frequent (daily) and chronic cannabis users. Occasional (e.g., once per month) cannabis users may be included at the discretion of the QI and if eligible, asked to stop cannabis use for study period Clinically significant abnormal laboratory results at screening as assessed by the QI Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI Individuals who are unable to give informed consent Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Lewis, PhD
Phone
1-226-242-4551
Ext
248
Email
elewis@kgkscience.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Crowley, MD
Organizational Affiliation
KGK Science Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
KGK Science Inc.
City
London
State/Province
Ontario
ZIP/Postal Code
N6B 3L1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Lewis, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Safety and Efficacy of Redsenol-1 Plus on Cancer-related Fatigue in Adults Who Have Received Cancer Treatment

We'll reach out to this number within 24 hrs